All Blog Posts Tagged 'therapy' - MedTech I.Q.2024-03-19T06:43:30Zhttp://medtechiq.ning.com/profiles/blog/feed?tag=therapy&xn_auth=noKnow more about Wearable Medical Devices | Operon Strategisttag:medtechiq.ning.com,2022-10-18:2140535:BlogPost:4730092022-10-18T06:41:13.000ZNehahttp://medtechiq.ning.com/profile/Neha
<p><span style="font-weight: 600;">The medical device industry changes constantly as new innovations and advancements are made in development, medical IT, and healthcare. Our medical device blog features expertise from the Sterling Medical Devices team and the latest information and regulation changes in the medical device industry that you should be aware of.</span></p>
<p></p>
<p><span style="font-weight: 600;">The healthcare and wellness industry is shifting toward regulated, personalized,…</span></p>
<p><span style="font-weight: 600;">The medical device industry changes constantly as new innovations and advancements are made in development, medical IT, and healthcare. Our medical device blog features expertise from the Sterling Medical Devices team and the latest information and regulation changes in the medical device industry that you should be aware of.</span></p>
<p></p>
<p><span style="font-weight: 600;">The healthcare and wellness industry is shifting toward regulated, personalized, and monitored healthcare. In a short period, mobile devices have skyrocketed in use. With these advancements, wearable devices such as - well-being tools, health monitors, fitness devices, and disease prevention devices are becoming more vital in the healthcare field.</span></p>
<p></p>
<p><span style="font-weight: 600;">Today, artificial intelligence, robots, sensors, big data, radar technologies, IoT, and digital wearables can manage and prevent diseases. They can estimate blood pressure, body temperature, heart rate, and respiration and indicate risks such as declining health, worsening sickness, and other threatening situations like - increased blood pressure or breathing problems.</span></p>
<p></p>
<p><span style="font-weight: 600;">We have an experienced team of people who help companies /medical device manufacturers in streamlining their pathways for market approval. We have expertise in FDA & EUMDR regulatory compliance and also put efforts into error free deliverables. Feel free to contact us for any</span> <a href="https://operonstrategist.com/wearable-medical-devices/?utm_source=Article%20Submission&utm_medium=Off%20Page1&utm_campaign=Article%20Submission"><span style="font-weight: 600;">Wearable</span> <span style="font-weight: 600;">medical device</span></a> <span style="font-weight: 600;">regulatory assistance.</span></p>
<h2><span style="font-weight: 600;">How can wearable devices improve health?</span></h2>
<p><span style="font-weight: 600;">The last five years have seen an increase in digital wellness wearables that can collect data in real time and reveal the physical and chemical properties of the body to evaluate wellness. Wearables are small electronic devices that, when placed on your body, can help measure temperature, blood pressure, blood oxygen, breathing rate, sound, GPS location, elevation, physical movement, changes in direction, and the electrical activity of the heart, muscles, brain, and skin.</span></p>
<p></p>
<h2><span style="font-weight: 600;">How is Wearable Technology used in Healthcare Nowadays?</span></h2>
<ul>
<li style="font-weight: 600;"><span style="font-weight: 600;">Tracking Health Status</span><span style="font-weight: 600;"><br/></span><span style="font-weight: 600;">With a health monitoring device, doctors can track and measure their patient's vitals in real-time such as heart rate, ECG, blood pressure, body temperature, etc.; the gadgets can transmit the necessary patients' data to the doctors for further examination.</span></li>
<li style="font-weight: 600;"><span style="font-weight: 600;">Therapeutic Treatment</span><span style="font-weight: 600;"><br/></span><span style="font-weight: 600;">Patients with chronic diseases can get timely treatment once their metrics exceed the level, e.g. getting automated insulin pumps or medications. Moreover, with these devices, doctors can better adjust the patients' therapy by monitoring their patients' conditions.</span></li>
<li style="font-weight: 600;"><span style="font-weight: 600;">Health and Activity Tracking</span><span style="font-weight: 600;"><br/></span><span style="font-weight: 600;">Apart from doctors monitoring their patients' states, wearable gadget users can track their health status and follow a healthy lifestyle. This includes sleep pattern tracking, heart rate monitoring, blood oxygen concentration or SpO2 monitoring, calorie tracking, steps, swimming tracking, etc. In case of any irregularities, they can seek consultation from a qualified doctor to take preventative action against any disease development.</span></li>
<li style="font-weight: 600;"><span style="font-weight: 600;">Other Uses</span><span style="font-weight: 600;"><br/></span><span style="font-weight: 600;">Wearables can also help in the diagnosis, screening, and monitoring of psychological disorders like depression. It also improves patient management efficiency in hospitals. In addition, wireless transmission in wearable systems allows researchers to develop new types of point-of-care diagnostic tools.</span></li>
</ul>
<p></p>
<h2><span style="font-weight: 600;">Top 5 Wearable Devices in Healthcare</span></h2>
<ul>
<li style="font-weight: 600;"><span style="font-weight: 600;">Wearable Fitness Trackers</span><span style="font-weight: 600;"><br/></span><span style="font-weight: 600;">Some of the simplest and most original forms of wearable technology, wearable fitness trackers, are devices equipped with sensors to keep track of physical activity, heart rate, oxygen level, blood pressure, etc. These provide wearers with health and fitness guidance by syncing to various smartphone apps. Wearers can get a good idea of how healthy they are. Few wearable fitness monitors support the setting of daily fitness goals and show the progress made on those goals.</span></li>
<li style="font-weight: 600;"><span style="font-weight: 600;">Smart Health Watches</span><span style="font-weight: 600;"><br/></span><span style="font-weight: 600;">Smartwatches allow users to perform tasks they normally do on their phones - read notifications, send simple messages, and make phone calls, while also offering some of the exercise and health-tracking benefits of fitness trackers. A smartwatch sends you a notification that you need to do more exercises, or it can alarm you if you're exerting too much effort. Having a smartwatch that can effectively monitor your heart rate is a great way to avoid injuring yourself.</span></li>
<li style="font-weight: 600;"><span style="font-weight: 600;">Wearable ECG Monitors</span><span style="font-weight: 600;"><br/></span><span style="font-weight: 600;">Wearable ECG monitors are on the cutting edge of consumer electronics, and what sets these monitors apart from some smartwatches, is their ability to measure electrocardiograms or ECGs. Some personal-use ECG devices have built-in screens so you can see your heart rhythm on the monitor. Other devices connect to a smartphone or computer application where you can record, view, store, and share your ECG readings.</span></li>
<li style="font-weight: 600;"><span style="font-weight: 600;">Wearable Blood Pressure Monitors</span><span style="font-weight: 600;"><br/></span><span style="font-weight: 600;">Wearable blood pressure monitors are devices that you wear and that can easily and quickly measure the levels of your blood pressure. We are all used to those traditional devices that you can use now and then remove from your hand until you decide to use them once again, but things are changing in this industry, and people are coming up with all kinds of possible solutions. Well, this particular product is one of those possible and better solutions, since you have the opportunity to check your blood pressure wherever you are and without any trouble. All you need to do is have a device on your wrist that can do the measurement for you.</span></li>
<li style="font-weight: 600;"><span style="font-weight: 600;">Wearable biosensors</span><span style="font-weight: 600;"><br/></span><span style="font-weight: 600;">Wearable biosensors are portable electronic devices that enable real-time monitoring and feedback to the user on various biological and physiological indicators. They can provide real-time measurements of various biological parameters, including blood pressure, heart rate, temperature, respiratory rate, and activity levels. They create two-way feedback between the user and their doctor and enable continuous and noninvasive disease diagnosis and health monitoring from physical motion and biofluids.</span></li>
</ul>
<p></p>
<p><span style="font-weight: 600;">Read more articles -</span></p>
<ol>
<li style="font-weight: 600;"><a href="https://operonstrategist.com/services/regulatory-approvals/fda-510k/?utm_source=Social+Bookmarking&utm_medium=Off+page+&utm_campaign=Social+Bookmarking"><span style="font-weight: 600;">FDA 510k Clearance process consulting</span></a></li>
<li style="font-weight: 600;"><a href="https://operonstrategist.com/services/regulatory-approvals/cdsco-registration/cdsco-import-license/?utm_source=Article%20Submission&utm_medium=Off%20Page1&utm_campaign=Article%20Submission"><span style="font-weight: 600;">CDSCO issues Medical devices importing license</span></a></li>
<li style="font-weight: 600;"><a href="https://operonstrategist.com/services/regulatory-approvals/ce-marking/?utm_source=Article+Submission&utm_medium=Off+page1&utm_campaign=Article+Submission"><span style="font-weight: 600;">get the CE approval with minimal efforts.</span></a></li>
</ol>
<p><br/><br/><br/><br/><br/><br/><br/><br/><br/><br/><br/><br/><br/><br/><br/></p>What is the UKCA Mark for Medical Device?tag:medtechiq.ning.com,2022-10-18:2140535:BlogPost:4729052022-10-18T06:40:19.000ZNehahttp://medtechiq.ning.com/profile/Neha
<p><span style="font-weight: 600;">UKCA stands for United Kingdom Conformity Assessed, and is applied to products placed on the market in the UK. This replaces the CE mark, which – pending changes to legislation - is recognised in the UK until the 30th June 2023. So from this date onwards, medical device manufacturers need to comply with the new UKCA marking regulations.</span></p>
<p></p>
<p><span style="font-weight: 600;">manufacturers now need to plan for how they will obtain a UK Conformity…</span></p>
<p><span style="font-weight: 600;">UKCA stands for United Kingdom Conformity Assessed, and is applied to products placed on the market in the UK. This replaces the CE mark, which – pending changes to legislation - is recognised in the UK until the 30th June 2023. So from this date onwards, medical device manufacturers need to comply with the new UKCA marking regulations.</span></p>
<p></p>
<p><span style="font-weight: 600;">manufacturers now need to plan for how they will obtain a UK Conformity Assessment mark before 30th June 2023. As many have seen, there have been delays in obtaining the mark, so the quicker manufacturers act, the better.</span></p>
<p></p>
<p><span style="font-weight: 600;">Operon strategist is medical devices consulting</span> <span style="font-weight: 600;">has a good experience in consultation and regulatory expertise for manufacturers and suppliers of medical devices. for any medical device registration process,</span> <a href="https://operonstrategist.com/ukca-marking-for-medical-devices/?utm_source=Article+submission&utm_medium=Off+page1&utm_campaign=Article+submission"><span style="font-weight: 600;">UKCA marking</span></a> <span style="font-weight: 600;">and licensing you can connect with us.</span></p>
<h2><span style="font-weight: 600;">WHAT ARE THE REQUIREMENTS FOR CE MARKED PRODUCTS IN THE UK?</span></h2>
<p><span style="font-weight: 600;">From 1 January 2021, there are a number of requirements that products marketed as medical devices in Great Britain (England, Wales and Scotland) must comply with:</span></p>
<p><span style="font-weight: 600;">Certificates issued by notified bodies recognised by the EU will remain valid for the UK market until 30 June 2023.</span></p>
<p><span style="font-weight: 600;">The EU no longer recognises the UK’s notified bodies.</span></p>
<p><span style="font-weight: 600;">UK Notified Bodies cannot issue CE certificates (except for the purposes of the “CE UKNI” mark, which is valid in Northern Ireland), and have become UK Approved Bodies.</span></p>
<p><span style="font-weight: 600;">A new route to market and product marking is available for manufacturers wishing to obtain UKCA marking for medical devices.</span></p>
<p></p>
<p><span style="font-weight: 600;">From 1 January 2021, all medical devices, including in vitro diagnostic (IVD) medical devices, marketed in Great Britain must be registered with the MHRA. There is a grace period for registration:</span></p>
<ul>
<li style="font-weight: 600;"><span style="font-weight: 600;">Class III and Class IIb implantables, and all active implantable medical devices and IVD List A products must be registered by 1 May 2021.</span></li>
<li style="font-weight: 600;"><span style="font-weight: 600;">Other Class IIb devices and all Class IIa devices and Schedule B IVD products and self-testing IVDs must be registered from 1 September 2021.</span></li>
<li style="font-weight: 600;"><span style="font-weight: 600;">Class I devices, custom-made devices and general IVDs must be registered from 1 January 2022</span></li>
<li style="font-weight: 600;"><span style="font-weight: 600;">Class I devices, custom-made devices and general IVDs that, prior to 1 January 2021, were required to register their devices with the MHRA (i.e. UK-based manufacturers or third country manufacturers with authorised representatives based in Northern Ireland) must continue to register their devices from 1 January 2021.</span></li>
</ul>
<p></p>
<h2><span style="font-weight: 600;">So what is the difference between what you have to do to place a CE Mark on a product versus a UKCA Mark?</span></h2>
<p></p>
<p><span style="font-weight: 600;">There are two levels to this answer:</span></p>
<ul>
<li style="font-weight: 600;"><span style="font-weight: 600;">The mechanics of UKCA-marking</span></li>
<li style="font-weight: 600;"><span style="font-weight: 600;">The regulatory basis for conformity assessment</span></li>
</ul>
<p><span style="font-weight: 600;">The mechanics are that a UK Approved Body will need to perform the conformity assessments that formerly the EU Notified Body (NB) would do. It appears that the two UK-based NBs that are able to do the necessary for medical imaging products will become UK Approved Bodies automatically, so not much change there, except that they will need to authorise both a CE mark and (in due course) a UKCA mark (likely at an extra fee). It is not clear whether EU-based Notified Bodies will be allowed, and at what point in time, register as UK Approved Bodies.</span></p>
<p></p>
<p><span style="font-weight: 600;">Additionally, while the UK standards will be the same in substance and with the same reference as the standards used in the EU, they will use the prefix ‘BS’ to indicate that they are standards adopted by the British Standards Institution as the UK’s national standards body. All references to standards in any regulatory documentation to be submitted for a UKCA assessment would therefore have to be updated with the ‘BS’ prefix.</span></p>
<p></p>
<h2><span style="font-weight: 600;">For Class I & general IVD:</span></h2>
<p><span style="font-weight: 600;">Class I device or general IVD do not third-party conformity assessment. Class, I device manufacturers must self-declare that the device meets the UK MDR criteria. If a class I device has any sterile or measuring functions, the manufacturer needs to approach the UK-approved body for the conformity assessment.</span></p>
<h2><span style="font-weight: 600;">For Class IIa, Class IIb, Class III, IVD:</span></h2>
<p><span style="font-weight: 600;">For Class IIa, Class IIb, Class III, IVD medical devices involvement of a UK-approved body is necessary to undergo a conformity assessment procedure. After approval from a UK-approved body, a manufacturer can declare that devices conform with the UK MDR 2002 and place it on the market.</span></p>
<p><span style="font-weight: 600;">All class medical device manufacturers must sign a ‘declaration of conformity before placing the UKCA marking on their product. The manufacturer needs to include the name of the UK-approved body if it is involved.</span></p>
<p></p>
<p><span style="font-weight: 600;">Read more articles -</span></p>
<ol>
<li style="font-weight: 600;"><a href="https://operonstrategist.com/services/regulatory-approvals/fda-510k/?utm_source=Social+Bookmarking&utm_medium=Off+page+&utm_campaign=Social+Bookmarking"><span style="font-weight: 600;">FDA 510k Clearance process consulting</span></a></li>
<li style="font-weight: 600;"><a href="https://operonstrategist.com/services/regulatory-approvals/cdsco-registration/cdsco-import-license/?utm_source=Article%20Submission&utm_medium=Off%20Page1&utm_campaign=Article%20Submission"><span style="font-weight: 600;">CDSCO issues Medical devices importing license</span></a></li>
<li style="font-weight: 600;"><a href="https://operonstrategist.com/services/regulatory-approvals/ce-marking/?utm_source=Article+Submission&utm_medium=Off+page1&utm_campaign=Article+Submission"><span style="font-weight: 600;">get the CE approval with minimal efforts.</span></a></li>
</ol>Consultation about FDA 510 k clearance and submissiontag:medtechiq.ning.com,2022-09-30:2140535:BlogPost:4727252022-09-30T05:47:16.000ZNehahttp://medtechiq.ning.com/profile/Neha
<p><b>What Does a FDA 510( k) Clearance mean?</b></p>
<p></p>
<p><span style="font-weight: 400;">Medical devices for human use within the United States must be submitted to the FDA to determine if the product is safe and effective. To do this, in utmost cases a company must compare their product to one formerly cleared by the FDA and give substantiation that their product is “ substantially equivalent ” to the preliminarily cleared( legally marketed) device. To be mainly original, the product…</span></p>
<p><b>What Does a FDA 510( k) Clearance mean?</b></p>
<p></p>
<p><span style="font-weight: 400;">Medical devices for human use within the United States must be submitted to the FDA to determine if the product is safe and effective. To do this, in utmost cases a company must compare their product to one formerly cleared by the FDA and give substantiation that their product is “ substantially equivalent ” to the preliminarily cleared( legally marketed) device. To be mainly original, the product must meet criteria for the same intended use, have the same technology or( slightly) different technology but produces similar end results, and be safe and effective.1 Once “pre-market clearance ” is took from the FDA the device can be distributed commercially immediately.</span></p>
<p></p>
<p><span style="font-weight: 400;">There are important differences between “ cleared ” and “ approved ”. When a medical device is cleared, this means it has experienced a 510( k) submission, which FDA has reviewed and handed clearance. For Class III medical devices to be legally marketed they must suffer a rigorous review and approval process orpre-market approval( PMA).</span></p>
<p></p>
<p><span style="font-weight: 400;">In the United States, this frequently means submitting a 510( k). A 510( k) is a structured package of information about your device and its performance and safety that you submit to the Food and Drug Administration( FDA) for “ clearance ” before you can deal your device in the U.S. In order to receive clearance from the FDA, your 510( k) will need to demonstrate that your medical device is substantially equivalent to another legally marketed device (called a predicate device).</span></p>
<p></p>
<p><b>What Exactly is Substantial Equivalence?</b></p>
<p></p>
<p><span style="font-weight: 400;">Now that we know what a 510( k) is, let’s talk about the substantial equivalence standard. You ’ll recall from the intro that your 510( k) must show that the new( or modified) device is substantially equivalent to at least one other legally marketed device, called a predicate device. Substantial equivalence looks at the intended use and the technological characteristics of the two devices.</span></p>
<p></p>
<p><b>Operon Strategist</b> <span style="font-weight: 400;">is a leading medical device consultant providing</span> <a href="https://operonstrategist.com/services/regulatory-approvals/fda-510k/?utm_source=Social+Bookmarking&utm_medium=Off+page+&utm_campaign=Social+Bookmarking"><b>FDA 510k Clearance process consulting to the customers</b></a> <span style="font-weight: 400;">to register SBU( Small Business Unit), if applicable. Take out the testing demand of the product, creation of the dossier, resolving the queries and after completion of all the conditioning, the customer receives the US FDA 510 k premarket approval. We also help with the establishment enrollment and device listings to make suitable the supply of medical devices in the US.</span></p>
<p><span style="font-weight: 400;">We helps during the process of submitting operations for class I, II, III medical devices at any stages of the product development. Our team of good experts will successfully prepare and submit FDA medical device regulatory documents for theU.S and international customers. These operations include </span></p>
<ul>
<li style="font-weight: 400;"><span style="font-weight: 400;">510( k) Premarket Notifications </span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">Premarket Approval Applications( PMAs) </span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">De Novo Request( Application) </span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">513( g) Requests for Classification </span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">Investigational Device Exemption Applications( IDEs </span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">Investigational New Drug Applications( INDs)</span></li>
</ul>
<p> </p>
<p><b>510( k) Premarket Notifications</b></p>
<p><span style="font-weight: 400;">Operon Strategist provides answers to related questions </span></p>
<ul>
<li style="font-weight: 400;"><span style="font-weight: 400;">Which groups( Class I, II, and III) do we require an FDA 510( k)? </span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">How many stages consist of the 510( k) application process? </span></li>
</ul>
<p><span style="font-weight: 400;">A class I, II, and III device intended for human use, for which a Premarket Approval FDA operation( PMA) isn't needed, must submit a 510( k) to FDA unless the device is pure from 510( k) conditions of the Federal Food, Drug, and Cosmetic Act( the FD&C Act) and doesn't exceed the limitations of exemptions in.9 of the device classification regulation chapters(e.g., 21 CFR862.9, 21 CFR864.9). Technically, under the 510( k) process, the FDA doesn't “ authorize ” medical devices and IVDs; the FDA issues a “ clearance ” or “ Approval ” for deal in the United States. typically, the FDA shall be subject to a provision of 510( k), should manufacturers intend to deal the Class II Medical Devices and some needed Class I and III bias or IVDs on the US market. Apre-market 510( k) approval is also required for already approved medical devices( Predicate) if the manufacturer( s) modifies the technology or changed the intent of device operation in a way that significantly affects patient safety or device performance. </span></p>
<p><span style="font-weight: 400;">The 510( k) is generally the most effective route to market clearance in the U.S. because you show your device is safe and effective based on this substantial equivalence standard, rather of demanding to present more expansive clinical trial data. </span></p>
<p><span style="font-weight: 400;">There are three types of 510( k) Traditional, shortened, and Special. This eBook will begin with a general overview of the 510( k) process, including its purpose and benefits. Next, we will explore the Traditional 510( k) and the sections and factors needed in depth. Finally, we will look at the Special and shortened 510( k). </span></p>
<p><b>When is a 510( k) needed? </b></p>
<p><span style="font-weight: 400;">A 510( k) is needed for medium risk devices that have a predicate on the market which can be used to demonstrate the safety and effectiveness of the new device. Meanwhile, a PMA is needed for high- risk or new devices which bear a advanced position of scrutiny to be verified safe and effective. </span></p>
<p><b>Complaints </b></p>
<p><span style="font-weight: 400;">Still, the end user can file a complaint with the FDA or the manufacturer, If a FDA 510( k) cleared medical device isn't performing as intended. </span></p>
<p><span style="font-weight: 400;">The user or client can also file a complaint with the FDA if it knows that the manufacturer or his representative or distributor is making false marketing claims or incorrectly promoting the performance of their device. This is a straightforward process to insure that medical devices on the market are being held to strict standards to make sure it's being used safely and effectively</span></p>
<p><b>Things to Consider</b></p>
<p><span style="font-weight: 400;">Before choosing a product with a FDA 510( k) clearance, it's important to understand what the product is claiming to do. Similar products may not perform exactly the same due to differences in technology or manufacturing. It's also important to make sure to read the indications for use to know how to use the product properly. Eventually, test data that has been transferred to the FDA should be available to the end user, frequently in a confirmation guide or test report.</span></p>
<p><a href="https://operonstrategist.com/"><b>Operon Strategist</b></a> <span style="font-weight: 400;">is a medical device regulatory consulting company which provides regulatory advisory & guidance to various manufacturers in the healthcare industry to ensure the strategic development of these manufacturers.</span><a href="https://storage.ning.com/topology/rest/1.0/file/get/10831225491?profile=original" target="_blank" rel="noopener"><img src="https://storage.ning.com/topology/rest/1.0/file/get/10831225491?profile=RESIZE_710x" class="align-full"/></a></p>ISO 13485 - QMS Medical Device Certification Consultanttag:medtechiq.ning.com,2022-09-30:2140535:BlogPost:4728292022-09-30T05:44:55.000ZNehahttp://medtechiq.ning.com/profile/Neha
<p><span style="font-weight: 400;">The US Food and Drug Administration has published a largely anticipated proposed rule to harmonize its medical device quality management system( QMS) regulation, 21 CFR Part 820, to the ISO 13485 QMS standard. </span></p>
<p><span style="font-weight: 400;">FDA’s proposed rule “ would harmonize quality management system conditions for FDA- regulated devices with conditions used by numerous other regulatory authorities around the world, ” the agency countries.…</span></p>
<p><span style="font-weight: 400;">The US Food and Drug Administration has published a largely anticipated proposed rule to harmonize its medical device quality management system( QMS) regulation, 21 CFR Part 820, to the ISO 13485 QMS standard. </span></p>
<p><span style="font-weight: 400;">FDA’s proposed rule “ would harmonize quality management system conditions for FDA- regulated devices with conditions used by numerous other regulatory authorities around the world, ” the agency countries. Greater alignment of FDA Quality System Regulation( QSR) with ISO 13485, first proposed by the regulator in May 2018, would bring US QMS conditions for medical device manufacturers closer in line with quality system conditions in markets similar as the European Union, Japan and Australia, potentially streamlining medical device registration and compliance processes across the US and other markets.</span></p>
<p><br/><br/></p>
<p><b>What's ISO 13485 Quality Management System </b></p>
<p></p>
<p><span style="font-weight: 400;">How do you manage your Quality Management System? If you're like the majority of the medical device industry, chances are you have a QMS that's a combination of paper- based processes and general purpose tools, approximately held together by a group of people within your company-- generally document control. </span></p>
<p><span style="font-weight: 400;">It’s important because it's long overdue with the former interpretation being released 13 years before in 2003. </span></p>
<p><span style="font-weight: 400;">The 2016 standard is veritably much a bridge. What I mean is that this bridge explicitly describes and defines current QMS prospects for medical device companies. Prior to these advances being formally defined and documented in the standard, numerous of the best practices being advised and adopted were veritably ad hoc in nature and frequently sounded to be based on auditor opinions. </span></p>
<p><span style="font-weight: 400;"> </span></p>
<p><span style="font-weight: 400;">Medical device manufacturer should appoint an</span> <a href="https://operonstrategist.com/services/turnkey-project/quality-management-system/iso-13485/?utm_source=Article+Submission&utm_medium=Off+page1&utm_campaign=Article+Submission"><b>experienced ISO13485 consultant</b></a> <span style="font-weight: 400;">who can work on all risk class devices. The associations need to cover the safety and risk information during product life cycle as per ISO 13485 demand. As an ISO 13485 medical device consultant, Operon Strategist identify the specific regulatory demand for the product similar as MDR, FDA 510( k) during the perpetration. This helps manufacturer in the further process of CE mark medical device or FDA 510( k) clearance.</span></p>
<p><br/><br/></p>
<p><b>An Overview of the ISO 13485 Quality Manual for Life Sciences</b></p>
<p></p>
<p><span style="font-weight: 400;">The International Organization for Standardization( ISO) is an internal standard- setting group of representatives from public standards associations. </span></p>
<p><span style="font-weight: 400;">This group maintains a comprehensive set of standards for life sciences associations. These standards are generally referred to as ISO 13485 standards. The current version of ISO 13485( last streamlined in 2020) sets forth major manufacturing and quality guidelines for businesses in largely regulated industries. </span></p>
<p><span style="font-weight: 400;">To alleviate unforeseen danger and uphold universal quality control standards across the medical device manufacturing industry, an ISO 13485 quality homemade outlines the mission-critical quality control guidelines and QMS conditions needed to keep both users and manufacturers safe. </span></p>
<p><br/><br/></p>
<p><b>ISO 13485 Documentation Requirements</b></p>
<p></p>
<p><span style="font-weight: 400;">By now, you should be veritably familiar with the word “. still, also it did n’t be, if it is n’t proved. ” </span></p>
<p><span style="font-weight: 400;">Yes, documentation of QMS processes, quality events, and workflows is critically important. occasionally the notion of documentation can produce angst within a company. occasionally the idea of documentation is viewed as overly burdensome and frequently times unnecessary with little value added. </span></p>
<p><span style="font-weight: 400;">In my experience, utmost companies do produce quite a many burdens and obstacles regarding documentation. And it does n’t have to be this way. </span></p>
<p><span style="font-weight: 400;">Documentation should be about defining processes and maintaining the records needed to demonstrate these processes are being followed. Documentation is crucial for objective substantiation. Objective substantiation to support your employees through design, development, manufacturing, and support of medical devices. Objective substantiation to demonstrate that conditions are being addressed. </span></p>
<p><span style="font-weight: 400;">Establishing thorough, yet functional, document operation practices for your business is one of the most important foundational rudiments of a QMS.</span></p>
<p><br/><br/></p>
<p><b>Benefits of an ISO 13485 Quality Manual </b></p>
<p><span style="font-weight: 400;">A comprehensive ISO 13485 quality homemade serves as the nautical design for workers, guests, controllers, and others that come in contact with your life lores incipiency or scale- up. also, an up- to- date ISO 13485 quality homemade ensures that your association’s QMS noway falls below norms. </span></p>
<p><span style="font-weight: 400;">Another benefit of the ISO 13485 primer is the pledge of increased customer confidence. Some guests will not indeed ask to see further bribes if they've evidence of an active ISO instrument and access to a quality primer. From an functional viewpoint, taking the time to collect this collection of attestation is well worth the time and trouble.</span></p>
<p><br/><br/></p>
<p><b>Key elements of an ISO 13485 Quality Policy:</b><span style="font-weight: 400;"> </span></p>
<ul>
<li style="font-weight: 400;"><span style="font-weight: 400;">Adapt the policy to the association. </span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">Define a frame for setting your quality objects. </span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">Establish the commitment to meeting all conditions. </span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">Establish the operation commitment. </span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">Communicate the Quality Policy. </span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">insure the regular review of the Quality Policy.</span></li>
</ul>
<p></p>
<p><b>What's the ISO 13485 Quality Policy?</b><span style="font-weight: 400;"> </span></p>
<p></p>
<p><span style="font-weight: 400;">The Quality Policy should be the overall thing of the association, and is written by top operation in order to direct everyone in the association as to how medical devices will be created and delivered to the guests. </span></p>
<p><span style="font-weight: 400;">This top- position policy is intended to be communicated and understood by everyone in the company, so they can all follow one strategic direction on how product development happens and how conditions will be met. Commitment to quality can also be used throughout the association as a focus on how processes are performed, and as a companion for the quality objects of the association — those main enhancement aims that the company plans to achieve.</span></p>
<p></p>
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</ol>ISO 14001: What is Emergency Preparedness and Response?tag:medtechiq.ning.com,2020-03-10:2140535:BlogPost:2931802020-03-10T12:13:14.000ZAdam Fleminghttp://medtechiq.ning.com/profile/Compliance4all
<p>With any environmental management system (EMS) you will have identified potential problems that could occur, and you will need to plan a response so that you can quickly react to these emergencies.</p>
<p>This webinar will discuss these plans in detail so that you can not only meet the requirements of the Iso 14001 standard, but also reduce your environmental impact when problems occur.<br></br><br></br>In the webinar we will look at:</p>
<ul>
<li>What ISO 14001 means by an emergency…</li>
</ul>
<p>With any environmental management system (EMS) you will have identified potential problems that could occur, and you will need to plan a response so that you can quickly react to these emergencies.</p>
<p>This webinar will discuss these plans in detail so that you can not only meet the requirements of the Iso 14001 standard, but also reduce your environmental impact when problems occur.<br/><br/>In the webinar we will look at:</p>
<ul>
<li>What ISO 14001 means by an emergency response</li>
<li>What the ISO 14001 standard actually requires for emergency response planning</li>
<li>How to prepare simple yet effective emergency response plans for your EMS</li>
</ul>ISO 45001: What is Emergency Preparedness and Response?tag:medtechiq.ning.com,2020-03-10:2140535:BlogPost:2934332020-03-10T12:12:46.000ZAdam Fleminghttp://medtechiq.ning.com/profile/Compliance4all
<p>With any occupational health & safety management system (OHSMS) you will have identified potential problems that could occur, and you will need to plan a response so that you can quickly react to these emergencies.</p>
<p>This webinar will discuss these plans in detail so that you can not only meet the requirements of the Iso 14001 standard, but also reduce your OH&S impact when problems occur.<br></br><br></br>In the webinar we will look at:</p>
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<li>What ISO 45001 means by an emergency…</li>
</ul>
<p>With any occupational health & safety management system (OHSMS) you will have identified potential problems that could occur, and you will need to plan a response so that you can quickly react to these emergencies.</p>
<p>This webinar will discuss these plans in detail so that you can not only meet the requirements of the Iso 14001 standard, but also reduce your OH&S impact when problems occur.<br/><br/>In the webinar we will look at:</p>
<ul>
<li>What ISO 45001 means by an emergency response</li>
<li>What the ISO 45001 standard actually requires for emergency response planning</li>
<li>How to prepare simple yet effective emergency response plans for your OHSMS</li>
</ul>The Use of Statistical Process Control (SPC) Using Control Charts to Maintain Compliance in the Laboratorytag:medtechiq.ning.com,2020-03-09:2140535:BlogPost:2927122020-03-09T09:56:18.000ZAdam Fleminghttp://medtechiq.ning.com/profile/Compliance4all
<p>Attend this webinar to learn how to understand control charts and their underlying statistics, how to choose variables to monitor, how to maintain the records and to plan adjustments.</p>
<p>There will be examples and walkthroughs of control chart implementation and use. A review of the relevant statistics will also be done.</p>
<p>Attend this webinar to learn how to understand control charts and their underlying statistics, how to choose variables to monitor, how to maintain the records and to plan adjustments.</p>
<p>There will be examples and walkthroughs of control chart implementation and use. A review of the relevant statistics will also be done.</p>ISO 45001: What is Emergency Preparedness and Response?tag:medtechiq.ning.com,2020-03-09:2140535:BlogPost:2926622020-03-09T09:55:49.000ZAdam Fleminghttp://medtechiq.ning.com/profile/Compliance4all
<p>With any occupational health & safety management system (OHSMS) you will have identified potential problems that could occur, and you will need to plan a response so that you can quickly react to these emergencies.</p>
<p>This webinar will discuss these plans in detail so that you can not only meet the requirements of the Iso 14001 standard, but also reduce your OH&S impact when problems occur.<br></br><br></br>In the webinar we will look at:</p>
<ul>
<li>What ISO 45001 means by an emergency…</li>
</ul>
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<p>This webinar will discuss these plans in detail so that you can not only meet the requirements of the Iso 14001 standard, but also reduce your OH&S impact when problems occur.<br/><br/>In the webinar we will look at:</p>
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<li>What ISO 45001 means by an emergency response</li>
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<p>This webinar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products to your customers.</p>
<p>Learn how to prevent quality and compliance problems by having a strong system for supplier audit and management! This webinar will help you to understand the regulations and how you can translate them into an efficient and effective process for managing your suppliers.<br></br><br></br>You'll learn about the essential elements of…</p>
<p>This webinar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products to your customers.</p>
<p>Learn how to prevent quality and compliance problems by having a strong system for supplier audit and management! This webinar will help you to understand the regulations and how you can translate them into an efficient and effective process for managing your suppliers.<br/><br/>You'll learn about the essential elements of supplier audits. We'll discuss the process steps for supplier control and how it relates to other parts of your QMS including receiving and acceptance activities.<br/><br/>A well-designed supplier audit program can be an effective tool in understanding, communicating, and reducing quality and compliance risk.</p>Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integritytag:medtechiq.ning.com,2020-03-05:2140535:BlogPost:2883372020-03-05T11:23:03.000ZAdam Fleminghttp://medtechiq.ning.com/profile/Compliance4all
<p>This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.</p>
<p>What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session will make you a better Excel user, saving you time and costs.</p>
<p></p>
<p></p>
<p>This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.</p>
<p>What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session will make you a better Excel user, saving you time and costs.</p>
<p></p>
<p></p>Production and Process Controls for Medical Device Companiestag:medtechiq.ning.com,2020-03-05:2140535:BlogPost:2883352020-03-05T11:22:24.000ZAdam Fleminghttp://medtechiq.ning.com/profile/Compliance4all
<p>Production and Process Controls (P&PC) are one of the key capabilities necessary for medical device companies to consistently and effectively produce safe and effective products.</p>
<p>Because Production and Process Controls are so critical they are one of the major subsystems emphasized in inspections by the FDA.</p>
<p></p>
<p><span>Failure to adequately implement Production and Process Controls (P&PC) can lead to disaster for your company or even worse for your customer. And…</span></p>
<p>Production and Process Controls (P&PC) are one of the key capabilities necessary for medical device companies to consistently and effectively produce safe and effective products.</p>
<p>Because Production and Process Controls are so critical they are one of the major subsystems emphasized in inspections by the FDA.</p>
<p></p>
<p><span>Failure to adequately implement Production and Process Controls (P&PC) can lead to disaster for your company or even worse for your customer. And P&PC continues to be a leading cause of 483 and warning letter observations from the FDA.</span><br/><br/><span>Even more alarming, P&PC failures are a leading cause for complaints, malfunctions, and product recalls. This webinar can help you prevent serious issues such as these.</span><br/><br/><span>You'll learn about FDA quality system regulation expectations, and how you can successfully and efficiently establish these into your Quality Management System. Join us to learn the essentials of Production and Process Controls.</span></p>Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirementstag:medtechiq.ning.com,2020-03-05:2140535:BlogPost:2880772020-03-05T11:21:41.000ZAdam Fleminghttp://medtechiq.ning.com/profile/Compliance4all
<p>It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.</p>
<p>Also considered: Areas requiring frequent re-evaluation / update; Similarities and differences; Future trends; Typical DHF Table of Contents; Technical File or Design Dossier Table of Contents; The importance and usefulness of the "Essential…</p>
<p>It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.</p>
<p>Also considered: Areas requiring frequent re-evaluation / update; Similarities and differences; Future trends; Typical DHF Table of Contents; Technical File or Design Dossier Table of Contents; The importance and usefulness of the "Essential Requirements"; Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed; Parallel approaches to development. Finally, the differing approaches to file audits by the FDA and the Notified Body will be discussed.</p>Risk Management Courses, Preventing Absent Trainingtag:medtechiq.ning.com,2020-03-05:2140535:BlogPost:2883152020-03-05T09:19:27.000ZJoseph Wilcoxhttp://medtechiq.ning.com/profile/JosephWilcox
<p><a href="https://storage.ning.com/topology/rest/1.0/file/get/4012124316?profile=original" rel="noopener" target="_blank"><img class="align-center" height="212" src="https://storage.ning.com/topology/rest/1.0/file/get/4012124316?profile=RESIZE_710x" width="329"></img></a></p>
<p></p>
<p></p>
<p>The US business environment as well as those of other countries have experienced over the years significant risk events with significant negative risk consequences. In recent times there have been a plethora of risk episodes in the corporate world.</p>
<p>Many of these episodes could have been avoided or modified if the entities…</p>
<p><a href="https://storage.ning.com/topology/rest/1.0/file/get/4012124316?profile=original" target="_blank" rel="noopener"><img src="https://storage.ning.com/topology/rest/1.0/file/get/4012124316?profile=RESIZE_710x" class="align-center" width="329" height="212"/></a></p>
<p></p>
<p></p>
<p>The US business environment as well as those of other countries have experienced over the years significant risk events with significant negative risk consequences. In recent times there have been a plethora of risk episodes in the corporate world.</p>
<p>Many of these episodes could have been avoided or modified if the entities experiencing the risk episode had in place sound risk management practices. This presentation starts with a review of a risk management thought framework that supports the effective risk management standards that an entity should maintain.</p>
<p>It then places this risk management framework in a real-world context by examining actual risk episodes that were experienced due to the absence of sound risk management practices. The absent practices will be discussed in detail in the review of each case. In addition, the roles of an entity's Risk Management and Compliance functions will be brought out in each review.</p>
<p></p>
<p>Risk management education is typically provided via textbooks and classroom presentations, but education in these forms remain pretty much as theory to the learner. However, the use of Risk Management case studies as an educational vehicle provides an immediate understanding of risk management practices in the real world and takes them from being theory to being practical management tools. In addition, the identification of the severe consequences that resulted from a risk event will reinforce the value of having sound risk management practices.</p>
<p>This presentation displays nine real-life case studies each of which will define the risk event experienced, the background to the event, the negative consequences the event generated, the underlying risk conditions and causes that lead to the event and the risk management preventives that were absent.</p>
<p>The case studies collectively will aid in understanding the need for appropriate risk management policies, procedures and practices as well as serve as a blueprint for the employment of an organization’s Risk Management and Compliance functions. Lastly, it will address the concept of risk metrics.</p>
<p>Participants will not only find the case studies to be highly educational, but also extremely interesting pieces of corporate history.</p>
<p></p>
<h4>Speaker Profile</h4>
<p></p>
<div class="bold"><b>Robert Geary</b><span> </span>is the founder of Greenwich Risk Management Advisory Services “LLC” and services as the principal consultant on many of the firm’s consultancy mandates.<br/><br/>Robert has been a banking and finance industry professional for 49 years with 34 years serving in a variety of senior Treasury, financial markets, asset management and risk management roles at JP Morgan Chase & Co. During his career with JP Morgan Chase he served in the following positions:<span> </span><ul>
<li>Head of Chase Manhattan Bank’s euro and other offshore funding activities</li>
<li>Chase’s first Asia/Pacific Area Treasury and Financial Markets Executive located in Hong Kong with responsibility for the treasury, currency trading/sales activities and securities portfolios of Chase’s branches in nine countries that included the major centers of Japan, Hong Kong and Singapore</li>
<li>Western Hemisphere Area Treasury and Financial Markets Executive with similar responsibilities for Chase’s branches in South America, Canada, Panama and Puerto Rico</li>
<li>National Sales Manager for Chase Securities</li>
<li>Treasury and Financial Markets General Manager for Chase AMP Bank in Australia</li>
<li>Risk Management and Treasury Executive for Chase’s Asset Management and Private Bank organizations</li>
<li>Head of the risk management oversight function of Market, Credit and Operational Risk for Chase Asset Management</li>
<li>Managing Director and Head of Fiduciary Risk Management for the Corporation</li>
</ul>
<br/>During Robert’s career he has served on the Board of Directors of Chase Manhattan Overseas Banking Corporation as well as having served on numerous senior committees that included Chase’s Portfolio and Investment Strategy Committee, Tax Committee, International Asset/Liability Management Committee, Chase Investment Policy Committee, and Capital Markets & FX Risk Management Committee.<br/><br/>Robert holds a BA degree in Economics from Pace University and did graduate studies in finance at New York University Graduate School of Business. He has held Series 7 & 24 registrations and currently retains a Series 65 registration.<br/><br/>He is a certified FINRA Arbitrator and is a member of the Executive Advisory Board of St. John’s University Department of Accounting and Taxation.</div>
<p></p>
<p></p>
<p><span>More : <span style="font-size: 14pt;"><strong><a href="https://www.traininng.com/webinar/corporate-risk-management-case-studies---events/consequences-/causes/preventives-absent-201388live" target="_blank" rel="noopener">Traininng.com</a></strong></span></span></p>Latest Courses On FDCPA, Regulatory Changestag:medtechiq.ning.com,2020-03-05:2140535:BlogPost:2880662020-03-05T09:17:04.000ZJoseph Wilcoxhttp://medtechiq.ning.com/profile/JosephWilcox
<p><a href="https://storage.ning.com/topology/rest/1.0/file/get/4012078679?profile=original" rel="noopener" target="_blank"><img class="align-center" height="175" src="https://storage.ning.com/topology/rest/1.0/file/get/4012078679?profile=RESIZE_710x" width="311"></img></a></p>
<p>How the Fair Debt Collection Practices Act Works.</p>
<p>The FDCPA does not protect debtors from those who are attempting to collect a personal debt. If you owe money to the local hardware store, for example, and the owner of the store calls you to collect that debt, he is not a debt collector under the terms of this act. FDCPA only applies to…</p>
<p><a href="https://storage.ning.com/topology/rest/1.0/file/get/4012078679?profile=original" target="_blank" rel="noopener"><img src="https://storage.ning.com/topology/rest/1.0/file/get/4012078679?profile=RESIZE_710x" class="align-center" width="311" height="175"/></a></p>
<p>How the Fair Debt Collection Practices Act Works.</p>
<p>The FDCPA does not protect debtors from those who are attempting to collect a personal debt. If you owe money to the local hardware store, for example, and the owner of the store calls you to collect that debt, he is not a debt collector under the terms of this act. FDCPA only applies to third-party debt collectors, such as those who work for a debt collection agency. The law covers credit card debt, medical bills, student loans, mortgages, and other household debt.</p>
<p>The Act prohibits certain types of "abusive and deceptive" conduct when attempting to collect debts including the following:</p>
<ul>
<li>Hours for phone contact: contacting consumers by telephone outside of the hours of 8:00 a.m. to 9:00 p.m. local time. Additionally, if certain hours are inconvenient for consumers during the allowable time (those who work at night and sleep during the day) they may not be contacted during those times</li>
<li>Failure to cease communication upon request: communicating with consumers in any way (other than litigation) after receiving written notice that said consumer wishes no further communication or refuses to pay the alleged debt, with certain exceptions, including advising that collection efforts are being terminated or that the collector intends to file a lawsuit or pursue other remedies where permitted</li>
<li>Causing a telephone to ring or engaging any person in telephone conversation repeatedly or continuously: with intent to annoy, abuse, or harass any person at the called number.</li>
</ul>
<p>Required conduct</p>
<p>The Act requires debt collectors to do the following (among other requirements):</p>
<ul>
<li>Identify themselves and notify the consumer, in every communication, that the communication is from a debt collector, and in the initial communication that any information obtained will be used to effect collection of the debt</li>
<li>Give the name and address of the original creditor (company to which the debt was originally payable) upon the consumer's written request made within 30 days of receipt of the §1692g notice</li>
</ul>
<p> </p>
<p>We will be discussing the do's and don'ts of collections thereby assuring that collectors and collection management teams are best prepared to achieve their goals in safe and sound ways.</p>
<p></p>
<p>Collections practices have always been an integral part of financial services. There are many regulations impacting practices, policies and procedures. Consumer advocates, as well as governmental staff are constantly adjusting those regulations, in order to ensure fairness and sensitive treatment of clients. This means that it is imperative that we stay abreast of changes, not only in policies and regulations, but also in the social conscience.</p>
<p>So if you are concerned about what can and cannot be done when trying to collect moneys owed this webinar is for you. If you are planning on changing processes, policies or procedures or simply require just an update about the temperature of collection activity today, then you should plan on attending this webinar.</p>
<p></p>
<h4>Speaker Profile</h4>
<p></p>
<div class="bold"><b>Daniel A Clark</b><span> </span>has over 30 years experience in the financial industry. 19 of that in Risk Management and Internal Audit where he established risk based internal audit processes. He is an active speaker and contributor to industry conferences, publications and think tanks. His book, Dare to Be Different, An Auditors Personal guide to Excellence has been well received in the industry.<br/><br/>Dan has been a CAE for international banks, regional banks and was Director of Operations for Internal Audit at GE Capital. He now is providing Audit and Risk Advisory Services to various sectors of the market place.</div>
<p></p>
<p></p>
<p><span>More : <span style="font-size: 14pt;"><strong><a href="https://www.traininng.com/webinar/fdcpa:-deb-collections-today,-tomorrow-and-upcoming-regulatory-changes-201335live" target="_blank" rel="noopener">Traininng.com</a></strong></span></span></p>Ways To Manage Sensitive Dress Code, Dress Code Coursetag:medtechiq.ning.com,2020-03-05:2140535:BlogPost:2881532020-03-05T09:15:16.000ZJoseph Wilcoxhttp://medtechiq.ning.com/profile/JosephWilcox
<p><a href="https://storage.ning.com/topology/rest/1.0/file/get/4012064477?profile=original" rel="noopener" target="_blank"><img class="align-center" height="162" src="https://storage.ning.com/topology/rest/1.0/file/get/4012064477?profile=RESIZE_710x" width="288"></img></a></p>
<p><span>Communicating and enforcing dress code policies are essential. Learning to set and manage policies by working directly with internal managers, business partners and executives in handling issues such as inappropriate or provocative dress, unhygienic employees is important, as well as identify and mitigating any legal issues.(protected class…</span></p>
<p><a href="https://storage.ning.com/topology/rest/1.0/file/get/4012064477?profile=original" target="_blank" rel="noopener"><img src="https://storage.ning.com/topology/rest/1.0/file/get/4012064477?profile=RESIZE_710x" class="align-center" width="288" height="162"/></a></p>
<p><span>Communicating and enforcing dress code policies are essential. Learning to set and manage policies by working directly with internal managers, business partners and executives in handling issues such as inappropriate or provocative dress, unhygienic employees is important, as well as identify and mitigating any legal issues.(protected class considerations, working with the legal department, and working with employee requests for accommodations).</span></p>
<p></p>
<p>HR, which is frequently responsible for policy development, must work with other parts of the organization to ensure that dress codes are managed consistently and fairly.Dress and appearance policies now require organizations to develop strategies that align with employer goals and culture while protecting the employer from discrimination claims and protecting employees' rights.</p>
<p>This course will cover the business of dress and appearance requirements for HR or managers.</p>
<p>Implementing an easy-to-understand dress code can prevent problems from occurring and ensure your entire staff dresses consistently.</p>
<p></p>
<h4>Speaker Profile</h4>
<p></p>
<div class="bold"><b>Audrey Halpern</b><span> </span>is a soft skills training facilitator consultant with 20+ years of experience. Audrey’s is currently a faculty member of American Management Association where she trains communication skills.</div>
<p></p>
<p></p>
<p><span>More : <span style="font-size: 14pt;"><strong><a href="https://www.traininng.com/webinar/handling-sensitive-dress-code-issues-without-getting-sued-201343live" target="_blank" rel="noopener">Traininng.com</a></strong></span></span></p>How To Recover Your Failure As A Leader , Leadership Trainingtag:medtechiq.ning.com,2020-03-05:2140535:BlogPost:2882202020-03-05T09:13:10.000ZJoseph Wilcoxhttp://medtechiq.ning.com/profile/JosephWilcox
<p><a href="https://storage.ning.com/topology/rest/1.0/file/get/4012040694?profile=original" rel="noopener" target="_blank"><img class="align-center" height="142" src="https://storage.ning.com/topology/rest/1.0/file/get/4012040694?profile=RESIZE_710x" width="271"></img></a></p>
<p>A leader does not necessarily manage, but a manager had better be a good leader.</p>
<p>Why is leadership so important?</p>
<p>Without leadership, nothing gets done. Leadership brings the vision and ideas, and sets the course or direction. Managers ensure execution.</p>
<p>People don't leave companies, they leave bosses. Leadership is the most…</p>
<p><a href="https://storage.ning.com/topology/rest/1.0/file/get/4012040694?profile=original" target="_blank" rel="noopener"><img src="https://storage.ning.com/topology/rest/1.0/file/get/4012040694?profile=RESIZE_710x" class="align-center" width="271" height="142"/></a></p>
<p>A leader does not necessarily manage, but a manager had better be a good leader.</p>
<p>Why is leadership so important?</p>
<p>Without leadership, nothing gets done. Leadership brings the vision and ideas, and sets the course or direction. Managers ensure execution.</p>
<p>People don't leave companies, they leave bosses. Leadership is the most important factor in staff retention and productivity. Often people are uninspired or disgruntled but don't leave - they stay and become an anchor on the team, project or organization.</p>
<p>What makes a good leader?</p>
<p>Some people assert you have to be born a leader - in reality the skills, traits and attributes can be learned.</p>
<p>Attend this webinar and you will learn how to become a better leader - whether you are new to the game or are an experienced leader - you will find valuable ideas in this webinar.</p>
<p></p>
<p></p>
<ul>
<li>The subtleties of communications great leaders use to adapt their communications for any audience</li>
<li>What great leaders do to develop teams, foster relationships, and encourage productive, respectful conflict</li>
<li>The process used to create a Vision and Mission - equally important organization wide and for teams and projects - every endeavor needs them</li>
<li>How to ensure you have communicated your message clearly</li>
<li>Engaging strategic and tactical planning</li>
<li>Leading-edge people development processes</li>
<li>Coaching and mentoring skills</li>
</ul>
<h4>Speaker Profile</h4>
<p></p>
<div class="bold"><b>Michael Healey</b><span> </span>Since 1987 he has been consulting with businesses and organizations that understand the value of developing organizational culture and their people as a foundation for continual improvement and enhancing organizational capacity.<br/><br/>From large multi-national to entrepreneurial organizations, government and NGO's, and across the spectrum of executive, senior managers, supervisors and staff</div>
<p></p>
<p></p>
<p><span>More : <span style="font-size: 14pt;"><a href="https://www.traininng.com/webinar/7-reasons-leaders-fail--201328live" target="_blank" rel="noopener">Traininng.com</a></span></span></p>
<p></p>
<p><span style="font-size: 14pt;"><a href="https://storage.ning.com/topology/rest/1.0/file/get/4012040694?profile=original" target="_blank" rel="noopener"></a></span></p>How To Recover Your Failure As A Leader , Leadership Trainingtag:medtechiq.ning.com,2020-03-05:2140535:BlogPost:2881502020-03-05T09:13:09.000ZJoseph Wilcoxhttp://medtechiq.ning.com/profile/JosephWilcox
<p><a href="https://storage.ning.com/topology/rest/1.0/file/get/4012040694?profile=original" rel="noopener" target="_blank"><img class="align-center" height="142" src="https://storage.ning.com/topology/rest/1.0/file/get/4012040694?profile=RESIZE_710x" width="271"></img></a></p>
<p>A leader does not necessarily manage, but a manager had better be a good leader.</p>
<p>Why is leadership so important?</p>
<p>Without leadership, nothing gets done. Leadership brings the vision and ideas, and sets the course or direction. Managers ensure execution.</p>
<p>People don't leave companies, they leave bosses. Leadership is the most…</p>
<p><a href="https://storage.ning.com/topology/rest/1.0/file/get/4012040694?profile=original" target="_blank" rel="noopener"><img src="https://storage.ning.com/topology/rest/1.0/file/get/4012040694?profile=RESIZE_710x" class="align-center" width="271" height="142"/></a></p>
<p>A leader does not necessarily manage, but a manager had better be a good leader.</p>
<p>Why is leadership so important?</p>
<p>Without leadership, nothing gets done. Leadership brings the vision and ideas, and sets the course or direction. Managers ensure execution.</p>
<p>People don't leave companies, they leave bosses. Leadership is the most important factor in staff retention and productivity. Often people are uninspired or disgruntled but don't leave - they stay and become an anchor on the team, project or organization.</p>
<p>What makes a good leader?</p>
<p>Some people assert you have to be born a leader - in reality the skills, traits and attributes can be learned.</p>
<p>Attend this webinar and you will learn how to become a better leader - whether you are new to the game or are an experienced leader - you will find valuable ideas in this webinar.</p>
<p></p>
<p></p>
<ul>
<li>The subtleties of communications great leaders use to adapt their communications for any audience</li>
<li>What great leaders do to develop teams, foster relationships, and encourage productive, respectful conflict</li>
<li>The process used to create a Vision and Mission - equally important organization wide and for teams and projects - every endeavor needs them</li>
<li>How to ensure you have communicated your message clearly</li>
<li>Engaging strategic and tactical planning</li>
<li>Leading-edge people development processes</li>
<li>Coaching and mentoring skills</li>
</ul>
<h4>Speaker Profile</h4>
<p></p>
<div class="bold"><b>Michael Healey</b><span> </span>Since 1987 he has been consulting with businesses and organizations that understand the value of developing organizational culture and their people as a foundation for continual improvement and enhancing organizational capacity.<br/><br/>From large multi-national to entrepreneurial organizations, government and NGO's, and across the spectrum of executive, senior managers, supervisors and staff</div>
<p></p>
<p></p>
<p><span>More : <span style="font-size: 14pt;"><a href="https://www.traininng.com/webinar/7-reasons-leaders-fail--201328live" target="_blank" rel="noopener">Traininng.com</a></span></span></p>
<p></p>
<p><span style="font-size: 14pt;"><a href="https://storage.ning.com/topology/rest/1.0/file/get/4012040694?profile=original" target="_blank" rel="noopener"></a></span></p>How To Recover Your Failure As A Leader , Leadership Trainingtag:medtechiq.ning.com,2020-03-05:2140535:BlogPost:2882162020-03-05T09:12:58.000ZJoseph Wilcoxhttp://medtechiq.ning.com/profile/JosephWilcox
<p><a href="https://storage.ning.com/topology/rest/1.0/file/get/4012040694?profile=original" rel="noopener" target="_blank"><img class="align-center" height="142" src="https://storage.ning.com/topology/rest/1.0/file/get/4012040694?profile=RESIZE_710x" width="271"></img></a></p>
<p>A leader does not necessarily manage, but a manager had better be a good leader.</p>
<p>Why is leadership so important?</p>
<p>Without leadership, nothing gets done. Leadership brings the vision and ideas, and sets the course or direction. Managers ensure execution.</p>
<p>People don't leave companies, they leave bosses. Leadership is the most…</p>
<p><a href="https://storage.ning.com/topology/rest/1.0/file/get/4012040694?profile=original" target="_blank" rel="noopener"><img src="https://storage.ning.com/topology/rest/1.0/file/get/4012040694?profile=RESIZE_710x" class="align-center" width="271" height="142"/></a></p>
<p>A leader does not necessarily manage, but a manager had better be a good leader.</p>
<p>Why is leadership so important?</p>
<p>Without leadership, nothing gets done. Leadership brings the vision and ideas, and sets the course or direction. Managers ensure execution.</p>
<p>People don't leave companies, they leave bosses. Leadership is the most important factor in staff retention and productivity. Often people are uninspired or disgruntled but don't leave - they stay and become an anchor on the team, project or organization.</p>
<p>What makes a good leader?</p>
<p>Some people assert you have to be born a leader - in reality the skills, traits and attributes can be learned.</p>
<p>Attend this webinar and you will learn how to become a better leader - whether you are new to the game or are an experienced leader - you will find valuable ideas in this webinar.</p>
<p></p>
<p></p>
<ul>
<li>The subtleties of communications great leaders use to adapt their communications for any audience</li>
<li>What great leaders do to develop teams, foster relationships, and encourage productive, respectful conflict</li>
<li>The process used to create a Vision and Mission - equally important organization wide and for teams and projects - every endeavor needs them</li>
<li>How to ensure you have communicated your message clearly</li>
<li>Engaging strategic and tactical planning</li>
<li>Leading-edge people development processes</li>
<li>Coaching and mentoring skills</li>
</ul>
<h4>Speaker Profile</h4>
<p></p>
<div class="bold"><b>Michael Healey</b><span> </span>Since 1987 he has been consulting with businesses and organizations that understand the value of developing organizational culture and their people as a foundation for continual improvement and enhancing organizational capacity.<br/><br/>From large multi-national to entrepreneurial organizations, government and NGO's, and across the spectrum of executive, senior managers, supervisors and staff</div>
<p></p>
<p></p>
<p><span>More : <span style="font-size: 14pt;"><a href="https://www.traininng.com/webinar/7-reasons-leaders-fail--201328live" target="_blank" rel="noopener">Traininng.com</a></span></span></p>
<p></p>
<p><span style="font-size: 14pt;"><a href="https://storage.ning.com/topology/rest/1.0/file/get/4012040694?profile=original" target="_blank" rel="noopener"></a></span></p>Maintain Multi-Family Properties Course, Solve Property Issuestag:medtechiq.ning.com,2020-03-05:2140535:BlogPost:2883062020-03-05T09:00:00.000ZJoseph Wilcoxhttp://medtechiq.ning.com/profile/JosephWilcox
<p></p>
<p><span><a href="https://storage.ning.com/topology/rest/1.0/file/get/4013263926?profile=original" rel="noopener" target="_blank"><img class="align-center" height="189" src="https://storage.ning.com/topology/rest/1.0/file/get/4013263926?profile=RESIZE_710x" width="348"></img></a></span></p>
<p></p>
<p><span>Students will have a good understanding of everything involved in setting up a maintenance plan for their property. They will be able to catch the "little" things before they become a costly emergency. In addition, they will be able to create an accurate, working budget which will maximize productivity and minimize…</span></p>
<p></p>
<p><span><a href="https://storage.ning.com/topology/rest/1.0/file/get/4013263926?profile=original" target="_blank" rel="noopener"><img src="https://storage.ning.com/topology/rest/1.0/file/get/4013263926?profile=RESIZE_710x" class="align-center" width="348" height="189"/></a></span></p>
<p></p>
<p><span>Students will have a good understanding of everything involved in setting up a maintenance plan for their property. They will be able to catch the "little" things before they become a costly emergency. In addition, they will be able to create an accurate, working budget which will maximize productivity and minimize extra costs.</span></p>
<p></p>
<p><span>This course will teach the basics of setting up a maintenance plan for your property. By doing so you will have a guide to get things done most inexpensively while providing top not service to your resident. We will also learn the importance of inventory, applied time versus actual time and how to measure performance of staff. Also discussed will be how to manage costs in terms of personnel and materials.</span></p>
<p></p>
<ul>
<li>You will learn fundamentals of maintenance management</li>
<li>How to develop inspection and cost standards</li>
<li>Fundamentals of work scheduling</li>
<li>Understanding the finances of maintenance management</li>
<li>Managing maintenance personnel</li>
<li>Measuring and monitoring performance</li>
<li>What is applied time?</li>
<li>What is the biggest time waster for maintenance staff?</li>
<li>How to effectively develop a budget</li>
<li>How to set up a maintenance schedule</li>
<li>Economic life vs actual age when setting up replacement plan</li>
</ul>
<h4>Speaker Profile</h4>
<p></p>
<div class="bold"><b>Paul Flogstad</b><span> </span>has been involved in the real estate industry for the past 38 years. He has been involved in sales, construction, project management, appraisal, mortgage consulting and brokerage, property management and property management consulting/training.<br/> <br/> Through his consulting company, Property Management Solutions, he provides training and consulting services nationwide to owners, management companies, multi-housing associations, as well as state and federal agencies.<br/> <br/> He specializes in fair housing issues and has developed fair housing and outreach programs for governmental agencies as well as conducting seminars which are presented to property management companies, apartment associations and the general public. He also conducts research analysis for impediments to fair housing for grantees of federal CDBG funds.<br/> <br/> Most recently, he has been a consultant to the City of Sioux Falls and the State of South Dakota. In this assignment he has developed a fair housing awareness program that is one of the first of its kind in the nation. It involves a three pronged approach to fair housing awareness. This approach makes use of an ombudsman concept and has proven to be very effective in dealing with discrimination and landlord/tenant issues.<br/> <br/> For over twenty years was involved in appraisal of residential, multi-family, farm and commercial properties throughout the Midwest. Most recently, he was a consultant for affordable, multi-housing properties in 22 different states. This involved properties in HUD, Rural Development, HOME and Tax Credit programs.</div>
<p></p>
<p></p>
<p></p>
<p><span>More :<span style="font-size: 14pt;"> <a href="https://www.traininng.com/webinar/developing-a-maintenance-plan-for-multi-family-properties--201339live" target="_blank" rel="noopener">Traininng.com</a></span></span></p>
<p></p>New Payroll & Administration Rules,Overtime Rules Coursestag:medtechiq.ning.com,2020-03-05:2140535:BlogPost:2881552020-03-05T09:00:00.000ZJoseph Wilcoxhttp://medtechiq.ning.com/profile/JosephWilcox
<p><a href="https://storage.ning.com/topology/rest/1.0/file/get/4012142492?profile=original" rel="noopener" target="_blank"><img class="align-center" height="388" src="https://storage.ning.com/topology/rest/1.0/file/get/4012142492?profile=RESIZE_710x" width="689"></img></a> This webinar covers the complete context of payroll rules and administration made simple. It starts with the basic classification of workers properly classified as Contractors or Workers. Rules for Payment and administration of Contractors is outlined. Rules for workers classified as "Exempt" or "Non-exempt" based on FLSA .</p>
<p>Rules for payments to…</p>
<p><a href="https://storage.ning.com/topology/rest/1.0/file/get/4012142492?profile=original" target="_blank" rel="noopener"><img src="https://storage.ning.com/topology/rest/1.0/file/get/4012142492?profile=RESIZE_710x" class="align-center" width="689" height="388"/></a>This webinar covers the complete context of payroll rules and administration made simple. It starts with the basic classification of workers properly classified as Contractors or Workers. Rules for Payment and administration of Contractors is outlined. Rules for workers classified as "Exempt" or "Non-exempt" based on FLSA .</p>
<p>Rules for payments to exempt and non-exempt employees are examined. Overtime rules are outlined for non-exempt employees in addition to record keeping & reporting for all employees.</p>
<p>Webinar stresses that payroll administration is only accepted if perfect. Achieving perfection in payroll processing is the overall theme of this webinar</p>
<p></p>
<p>Payroll is most important aspect of any business. It leads to employee morale. It must be perfect and comply with all the rules. This webinar examines all the payroll rules of the FLSA and how to implement them to achieve perfection.</p>
<p>It is a simple approach to payroll rules and administration an guaranteed to give attendees a good working knowledge of payroll rules & administration in simple to understand and apply tools & techniques.</p>
<p></p>
<h4>Speaker Profile</h4>
<p></p>
<div class="bold"><b>Carl Young</b><span> </span>is an Author, Speaker, Trainer, Consultant, and Coach. He holds a MBA and completed graduate studies in Accounting and Taxation. He is a former CFO of a 275M, high growth technology based company. He has over 25 years of senior level business management experience. In addition, he has over 25 years of training experience in finance, accounting and business management. Former CEO of his own small parts manufacturing company as well as former Senior Financial Associate of major consulting firm.<br/> <br/> Carl is a member of the following organizations: American Society of Corporate Controllers, Council of Experts (investment firm Gersen & Lehrman), Society of Industry Leaders (sponsored by Standard & Poors), and the National Association of Accountants.<br/> <br/> An engaging and entertaining speaker and trainer who draws from his experience as a former CFO to make relevant teaching points. Sessions are rich in content, lively, full of energy and include plenty of audience interaction. He has branded himself as Mr. Simplicity! His goal is to make finance and accounting relevant to non-financial professionals using tools and techniques that are simple to understand and apply.</div>
<p></p>
<p></p>
<p><span>More : <span style="font-size: 14pt;"><strong><a href="https://www.traininng.com/webinar/payroll-rules-&-administration-made-simple-includes-review-of-new-overtime-rules-201376live" target="_blank" rel="noopener">Traininng.com</a></strong></span></span></p>Maintain Multi-Family Properties Course, Solve Property Issuestag:medtechiq.ning.com,2020-03-05:2140535:BlogPost:2880582020-03-05T09:00:00.000ZJoseph Wilcoxhttp://medtechiq.ning.com/profile/JosephWilcox
<p><a href="https://storage.ning.com/topology/rest/1.0/file/get/4013284626?profile=original" rel="noopener" target="_blank"><img class="align-center" height="213" src="https://storage.ning.com/topology/rest/1.0/file/get/4013284626?profile=RESIZE_710x" width="266"></img></a></p>
<p></p>
<p>Do you say "yes" at work when you would rather say "no?" Are you concerned with what others will think of you? In this essential webinar, you'll learn how effective you are at boundary-setting and why it can be hard for good people to say "no."</p>
<p>You'll find out how poor boundary-setting can lead to feeling fed up, overworked and…</p>
<p><a href="https://storage.ning.com/topology/rest/1.0/file/get/4013284626?profile=original" target="_blank" rel="noopener"><img src="https://storage.ning.com/topology/rest/1.0/file/get/4013284626?profile=RESIZE_710x" class="align-center" width="266" height="213"/></a></p>
<p></p>
<p>Do you say "yes" at work when you would rather say "no?" Are you concerned with what others will think of you? In this essential webinar, you'll learn how effective you are at boundary-setting and why it can be hard for good people to say "no."</p>
<p>You'll find out how poor boundary-setting can lead to feeling fed up, overworked and resentful to the point of depression and illness.</p>
<p>You'll discover how good boundaries can protect you from being manipulated, used or violated by others. Finally, you'll learn keys to establish boundaries in a range of typical work situations.</p>
<p></p>
<p>Not setting healthy boundaries can impact your level of job performance and career success on an extreme level. When you don't have healthy boundaries, you may find yourself with much more work than you can handle, too many responsibilities and work that isn't even your job to do.</p>
<p>At a time when organizations are feeling pressured to produce more with less, employees at finding themselves pushed beyond measure, sometimes performing the work of 2-3 employees. This can happen when employees are fearful of saying "no," thinking their job will be on the line if they don't say "yes."</p>
<p></p>
<h4>Speaker Profile</h4>
<p></p>
<div class="bold"><b>Dr. Miriam Reiss</b><span> </span>blends strong executive, leadership and career coaching skills with proven client success. Miriam has been a leader in the coaching industry for over two decades.<br/> <br/> Miriam's results-driven approach holds clients to the highest standard and supports them in peak performance. Her style combines wisdom, strategy and leading edge resources. She is a specialist in career and leadership development, neuroscience, marketing and wellness. Miriam has coached individuals at all levels in a wide spectrum of industries and has worked with employees representing companies ranging from Microsoft, Fidelity and Boeing to the Peace Corps.<br/> <br/> Miriam’s background includes training in Applied Psychology and Professional Coaching. She is certified by the International Coaching Federation as a Master Coach and holds degrees from Cornell and Columbia Universities.</div>
<p></p>
<p></p>
<p><span>More : <span style="font-size: 14pt;"><a href="https://www.traininng.com/webinar/healthy-boundaries:-critical-tools-for-workplace-success%E2%84%A2--201380live" target="_blank" rel="noopener">Traininng.com</a></span></span></p>Quick PowerPoint Presentation Courses, PowerPoint Coursetag:medtechiq.ning.com,2020-03-05:2140535:BlogPost:2880542020-03-05T09:00:00.000ZJoseph Wilcoxhttp://medtechiq.ning.com/profile/JosephWilcox
<p><a href="https://storage.ning.com/topology/rest/1.0/file/get/4013249758?profile=original" rel="noopener" target="_blank"><img class="align-center" height="241" src="https://storage.ning.com/topology/rest/1.0/file/get/4013249758?profile=RESIZE_710x" width="241"></img></a></p>
<p></p>
<p>We'll begin by showing you how and why you should begin every presentation with an outline. The outline then becomes the framework of the presentation itself. Then we cover how to create and apply Microsoft Themes to get the precise look and feel that represents your organization's identity.</p>
<p>You'll see how to take your current company…</p>
<p><a href="https://storage.ning.com/topology/rest/1.0/file/get/4013249758?profile=original" target="_blank" rel="noopener"><img src="https://storage.ning.com/topology/rest/1.0/file/get/4013249758?profile=RESIZE_710x" class="align-center" width="241" height="241"/></a></p>
<p></p>
<p>We'll begin by showing you how and why you should begin every presentation with an outline. The outline then becomes the framework of the presentation itself. Then we cover how to create and apply Microsoft Themes to get the precise look and feel that represents your organization's identity.</p>
<p>You'll see how to take your current company presentation template and turn it into a theme that can be repurposed all throughout Microsoft Office.</p>
<p>You will finally understand how to leverage the Slide Master to create multiple slide layouts that are consistent from presentation to presentation. With a firm grasp of Slide Masters, the days of tweaking individual slides for formatting will finally be over.</p>
<p>From there we discuss how to enhance and add content to get your ideas across as optimally as possible, why bullet points aren't always the best idea, and how to apply animation purposefully. Finally we look at how to deal with specific types of content like photos, charts, and diagrams.</p>
<p></p>
<p>PowerPoint is the tool business professionals use most often. But, most people are not using it optimally, the way it was intended. So, the average presentation can take hour upon frustrating hour to put together. As an international speaker and trainer, presentation media is my stock in trade.</p>
<p>With over 60 presentations to do a year, I want to work the most efficiently I can. Whether you do 6 or 60, so do you! Your time and talent are valuable! So, why would you waste any of it fighting the application to get across your ideas effectively? Not only will the methods shown to you in this program potentially cut the time it takes to craft an impactful presentation by more than half, it will also reduce the frustration to almost nothing!</p>
<p></p>
<h4>Speaker Profile</h4>
<p></p>
<div class="bold"><b>Melissa Esquibel</b><span> </span>specializes in transforming those confused by technology into empowered users of their software tools. As a Microsoft Certified Trainer (MCT) with more than 30 years in business application technology, Melissa has a unique ability to make learning programs enjoyable AND valuable. Melissa's consulting career spans banking, manufacturing, telecommunications, energy and insurance, which allows her to provide real-world examples and applications. She has enabled everyone from rocket scientists to real estate brokers to put the "productive" back in office productivity software. Melissa graduated summa cum laude from Strayer University with a Bachelor of Business Administration, majoring in Legal Studies.</div>
<p></p>
<p></p>
<p><span>More : <span style="font-size: 14pt;"><a href="https://www.traininng.com/webinar/powerpoint-on-the-fast-track:-presentations-in-minutes-not-hours--201374live" target="_blank" rel="noopener">Traininng.com</a></span></span></p>New Courses On Macros and Intro to VBA , Excel macro tutorialtag:medtechiq.ning.com,2020-03-05:2140535:BlogPost:2880442020-03-05T08:30:00.000ZJoseph Wilcoxhttp://medtechiq.ning.com/profile/JosephWilcox
<p><a href="https://storage.ning.com/topology/rest/1.0/file/get/4013233438?profile=original" rel="noopener" target="_blank"><img class="align-center" height="184" src="https://storage.ning.com/topology/rest/1.0/file/get/4013233438?profile=RESIZE_710x" width="328"></img></a> Being able to create and edit a macro is one of the must have skills for Excel Power Users. Having this knowledge will save you hours of time by allowing you to automate any Excel-based task or process.</p>
<p>If you've never created macros or used Excel VBA before, this webinar is for you.</p>
<p>The advanced excel training will be delivered using Excel 2016…</p>
<p><a href="https://storage.ning.com/topology/rest/1.0/file/get/4013233438?profile=original" target="_blank" rel="noopener"><img src="https://storage.ning.com/topology/rest/1.0/file/get/4013233438?profile=RESIZE_710x" width="328" height="184" class="align-center"/></a>Being able to create and edit a macro is one of the must have skills for Excel Power Users. Having this knowledge will save you hours of time by allowing you to automate any Excel-based task or process.</p>
<p>If you've never created macros or used Excel VBA before, this webinar is for you.</p>
<p>The advanced excel training will be delivered using Excel 2016 for Windows although for users of earlier versions, most of the functionality is available in Excel 2010 and Excel 2013.</p>
<p></p>
<p>In this Excel macro tutorial you will learn how to create and edit macros, create macros that can be re-used across multiple files and create macros that run by clicking on buttons that you create. You'll learn how to create a macro the easy way by using the built-in macro recorder.</p>
<p>You'll then progress on to learn how to make simple changes to a macro using the built-in programming language called Excel VBA.</p>
<p></p>
<h4>Speaker Profile : </h4>
<p></p>
<div class="bold"><b>Cathy Horwitz</b><span> </span>Cathy Horwitz believes that when your employees know the capabilities of the software they use, they will demonstrate improved productivity, will be more efficient and will be able to problem solve more easily.<br/> <br/> Cathy teaches classes on the Microsoft suite of application software including Excel, PowerPoint, Word, Access and Outlook. Cathy has over 30 years of experience in classroom training and application support with personal computers and has been an instructor for the Microsoft Office Suite since 1989.<br/> <br/> Her strengths include customizing classes based on the needs of individual students and providing realistic business examples to compliment training. She is a high energy trainer with a flair for training the adult student.<br/> <br/> When not teaching, Cathy enjoys shopping estate sales and refinishing mid-century furniture.</div>
<div class="bold"></div>
<div class="bold"></div>
<div class="bold"></div>
<div class="bold"></div>
<div class="bold">More : <span style="font-size: 14pt;"><a href="https://www.traininng.com/webinar/macros-and-intro-to-vba--201367live" target="_blank" rel="noopener">Traininng.com</a></span></div>
<p></p>Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Conceptstag:medtechiq.ning.com,2020-02-24:2140535:BlogPost:2827022020-02-24T12:41:03.000ZAdam Fleminghttp://medtechiq.ning.com/profile/Compliance4all
<p></p>
<p>Documented Part 11 training, as with any FDA regulation, is required for staff members who have responsibilities within the scope of the regulation.</p>
<p>Understanding the requirements of Part 11 is critical to compliance with the regulation. Knowledge of regulatory requirements is an exercise in project management, and avoidance of non-compliance penalties.</p>
<ul>
<li>History and Overview</li>
<li>Subpart A: General Provisions</li>
<li>Subpart B: Electronic…</li>
</ul>
<p></p>
<p>Documented Part 11 training, as with any FDA regulation, is required for staff members who have responsibilities within the scope of the regulation.</p>
<p>Understanding the requirements of Part 11 is critical to compliance with the regulation. Knowledge of regulatory requirements is an exercise in project management, and avoidance of non-compliance penalties.</p>
<ul>
<li>History and Overview</li>
<li>Subpart A: General Provisions</li>
<li>Subpart B: Electronic Records</li>
<li>Subpart C: Electronic Signatures</li>
<li>Scope & Application Guidance</li>
<li>Questions and Answers</li>
</ul>Dietary Supplements CGMPS - 21 CFR 111 Compliancetag:medtechiq.ning.com,2020-02-24:2140535:BlogPost:2825322020-02-24T12:40:05.000ZAdam Fleminghttp://medtechiq.ning.com/profile/Compliance4all
<p>21 CFR part 111 ("the DS CGMP rule") requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the CGMPs.</p>
<p>This is to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.<br></br><br></br>This webinar will discuss basic Dietary Supplement CGMP of Part 111 and related requirements, to…</p>
<p>21 CFR part 111 ("the DS CGMP rule") requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the CGMPs.</p>
<p>This is to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.<br/><br/>This webinar will discuss basic Dietary Supplement CGMP of Part 111 and related requirements, to include:</p>
<ul>
<li>Quality Management System / QA / QC</li>
<li>Personnel, Facilities, Equipment</li>
<li>Software controls</li>
<li>Production and Process Controls</li>
<li>Holding and Distribution</li>
<li>Complaints and Returns</li>
<li>Records</li>
</ul>Validation of HPLC/UPLC Methodologiestag:medtechiq.ning.com,2020-02-24:2140535:BlogPost:2824002020-02-24T12:39:15.000ZAdam Fleminghttp://medtechiq.ning.com/profile/Compliance4all
<p></p>
<p>This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.</p>
<p><span>Instrumental liquid chromatography, either as HPLC or UPLC, are common techniques in laboratories that are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.</span><br></br><br></br><span>The focus of most validation work is on the methodology, the standard operating procedure…</span></p>
<p></p>
<p>This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.</p>
<p><span>Instrumental liquid chromatography, either as HPLC or UPLC, are common techniques in laboratories that are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.</span><br/><br/><span>The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of the instrumentation and other associated items of column, solvents, and other reagents and chemicals is also an area of focus in an audit.</span><br/><br/><span>For Good Laboratory Practice (GLP) or for ISO 17025 compliance, such methods must meet certain requirements. This presentation will cover the key elements to have a compliant method.</span></p>Validation of HPLC/UPLC Methodologiestag:medtechiq.ning.com,2020-02-24:2140535:BlogPost:2823962020-02-24T12:39:10.000ZAdam Fleminghttp://medtechiq.ning.com/profile/Compliance4all
<p></p>
<p>This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.</p>
<p><span>Instrumental liquid chromatography, either as HPLC or UPLC, are common techniques in laboratories that are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.</span><br></br><br></br><span>The focus of most validation work is on the methodology, the standard operating procedure…</span></p>
<p></p>
<p>This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.</p>
<p><span>Instrumental liquid chromatography, either as HPLC or UPLC, are common techniques in laboratories that are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.</span><br/><br/><span>The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of the instrumentation and other associated items of column, solvents, and other reagents and chemicals is also an area of focus in an audit.</span><br/><br/><span>For Good Laboratory Practice (GLP) or for ISO 17025 compliance, such methods must meet certain requirements. This presentation will cover the key elements to have a compliant method.</span></p>Writing Excellent SOPstag:medtechiq.ning.com,2020-02-19:2140535:BlogPost:2797622020-02-19T11:22:03.000ZAdam Fleminghttp://medtechiq.ning.com/profile/Compliance4all
<p>Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.</p>
<p>Well written SOPs that are easy to understand and follow are necessary to accomplish that objective. Excellent SOPs need more than just subject matter.<br></br><br></br>This webinar will help you to write complete, clear, unambiguous, and flexible SOPs. You will learn techniques for creating concise and easy to read SOPs that your employees can understand and will follow. Well…</p>
<p>Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.</p>
<p>Well written SOPs that are easy to understand and follow are necessary to accomplish that objective. Excellent SOPs need more than just subject matter.<br/><br/>This webinar will help you to write complete, clear, unambiguous, and flexible SOPs. You will learn techniques for creating concise and easy to read SOPs that your employees can understand and will follow. Well written SOPs result in more consistent process outputs and quality results.<br/><br/>Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed.<br/><br/>More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes, quality work, and predictable results.</p>Implementing an Effective CAPA Systemtag:medtechiq.ning.com,2020-02-19:2140535:BlogPost:2797602020-02-19T11:21:05.000ZAdam Fleminghttp://medtechiq.ning.com/profile/Compliance4all
<p>CAPA, no matter how you look at it, is the heart of the quality management system. CAPA can be viewed as and is the merging of change control, continuous improvement, and complaint management.</p>
<p>What does the CAPA system do for the organization? CAPA not only indicates the organization's ability to respond to problems that arise but also to proactively anticipate and prevent subsequent problems from arising.<br></br><br></br>This webinar highlights the various regulations governing CAPAs, how…</p>
<p>CAPA, no matter how you look at it, is the heart of the quality management system. CAPA can be viewed as and is the merging of change control, continuous improvement, and complaint management.</p>
<p>What does the CAPA system do for the organization? CAPA not only indicates the organization's ability to respond to problems that arise but also to proactively anticipate and prevent subsequent problems from arising.<br/><br/>This webinar highlights the various regulations governing CAPAs, how CAPAs are successfully initiated and managed, how CAPA is an integral part of the quality system, and how an effective failure investigation and root cause analysis is accomplished. During this webinar, emphasis is placed on the application and practical aspects of the process to include its critical steps, CAPA timing, participants to the process, roles and functions, and the pitfalls associated with CAPA investigations.<br/><br/>The content of the webinar will focus on the practical and how to best thoroughly accomplish an effective CAPA system. At the completion of this webinar, you will be able to:</p>
<ul>
<li>Explain the purpose and function of CAPA</li>
<li>Identify and explain the relevant CAPA regulations</li>
<li>Define exception/deviation reporting and explain the process of executing the reporting process</li>
<li>Explain and trace the CAPA flow from problem identification to resolution</li>
<li>Explain the challenges and pitfalls of the CAPA process and how they are overcome</li>
<li>Explain CAPA's role in risk mitigation</li>
<li>Explain how root cause analysis is executed</li>
</ul>Change Management Systemtag:medtechiq.ning.com,2020-02-19:2140535:BlogPost:2798792020-02-19T11:16:27.000ZAdam Fleminghttp://medtechiq.ning.com/profile/Compliance4all
<p>The presentation will focus on FDA responses to failures in Change Management.</p>
<p>The presentation shall describe how FDA expects firms to establish change management, the sources of change management, the outcomes from change management, and timely outcomes. We will cover some suggestions and Do's and Dont's.</p>
<p>The presentation will focus on FDA responses to failures in Change Management.</p>
<p>The presentation shall describe how FDA expects firms to establish change management, the sources of change management, the outcomes from change management, and timely outcomes. We will cover some suggestions and Do's and Dont's.</p>