Adam Fleming's Posts - MedTech I.Q.2024-03-29T11:45:45ZAdam Fleminghttps://medtechiq.ning.com/profile/Compliance4allhttps://storage.ning.com/topology/rest/1.0/file/get/2524273085?profile=RESIZE_48X48&width=48&height=48&crop=1%3A1https://medtechiq.ning.com/profiles/blog/feed?user=1k6hf2xgyp805&xn_auth=noISO 14001: What is Emergency Preparedness and Response?tag:medtechiq.ning.com,2020-03-10:2140535:BlogPost:2931802020-03-10T12:13:14.000ZAdam Fleminghttps://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 Fleminghttps://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>
<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 Fleminghttps://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 Fleminghttps://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>
<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>Supplier Auditing for Medical Device Companiestag:medtechiq.ning.com,2020-03-09:2140535:BlogPost:2926602020-03-09T09:54:47.000ZAdam Fleminghttps://medtechiq.ning.com/profile/Compliance4all
<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 Fleminghttps://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 Fleminghttps://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 Fleminghttps://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>Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Conceptstag:medtechiq.ning.com,2020-02-24:2140535:BlogPost:2827022020-02-24T12:41:03.000ZAdam Fleminghttps://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 Fleminghttps://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 Fleminghttps://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 Fleminghttps://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 Fleminghttps://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 Fleminghttps://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 Fleminghttps://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>3-Hour Virtual Seminar on FDA's section 804 Drug and 801(d)(1)(B) Biologic Importation Programstag:medtechiq.ning.com,2020-02-19:2140535:BlogPost:2798772020-02-19T11:15:49.000ZAdam Fleminghttps://medtechiq.ning.com/profile/Compliance4all
<p>This presentation outlines the two proposed pathways through which HHS and FDA will allow for the importation of certain drugs originally intended for non-US markets.</p>
<p>Notably, both pathways rely on parties other than the federal government-such as states, wholesalers, pharmacists, and manufacturers-to demonstrate that eligible drugs can be imported into the US safely and with the required cost savings.</p>
<p>This presentation outlines the two proposed pathways through which HHS and FDA will allow for the importation of certain drugs originally intended for non-US markets.</p>
<p>Notably, both pathways rely on parties other than the federal government-such as states, wholesalers, pharmacists, and manufacturers-to demonstrate that eligible drugs can be imported into the US safely and with the required cost savings.</p>Metrology: Statistical Analysis of Measurement Uncertaintytag:medtechiq.ning.com,2020-02-19:2140535:BlogPost:2799422020-02-19T11:15:10.000ZAdam Fleminghttps://medtechiq.ning.com/profile/Compliance4all
<p>The webinar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and "uncertainty ratios".</p>
<p>Several of the standard methods for analyzing measurement variation are then described and explained, as derived from AIAG's Measurement System Analysis reference book. The methods include: Gage R&R (ANOVA method, for 3 gages, 3 persons, 3 replicates, and 10 parts), Gage Correlation (for 3 gages), Gage…</p>
<p>The webinar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and "uncertainty ratios".</p>
<p>Several of the standard methods for analyzing measurement variation are then described and explained, as derived from AIAG's Measurement System Analysis reference book. The methods include: Gage R&R (ANOVA method, for 3 gages, 3 persons, 3 replicates, and 10 parts), Gage Correlation (for 3 gages), Gage Linearity, and Gage Bias. The webinar ends with an explanation of how to combine all relevant uncertainty information into an "Uncertainty Budget" that helps determine the appropriate width of QC specification intervals (i.e., "guard-banded specifications"). Spreadsheets are used to demonstrate how to perform the methods described during the webinar.</p>3-Hour Virtual Seminar on FDA's section 804 Drug and 801(d)(1)(B) Biologic Importation Programstag:medtechiq.ning.com,2020-02-17:2140535:BlogPost:2792212020-02-17T11:44:49.000ZAdam Fleminghttps://medtechiq.ning.com/profile/Compliance4all
<p>This presentation outlines the two proposed pathways through which HHS and FDA will allow for the importation of certain drugs originally intended for non-US markets.</p>
<p>Notably, both pathways rely on parties other than the federal government-such as states, wholesalers, pharmacists, and manufacturers-to demonstrate that eligible drugs can be imported into the US safely and with the required cost savings.</p>
<p>This presentation outlines the two proposed pathways through which HHS and FDA will allow for the importation of certain drugs originally intended for non-US markets.</p>
<p>Notably, both pathways rely on parties other than the federal government-such as states, wholesalers, pharmacists, and manufacturers-to demonstrate that eligible drugs can be imported into the US safely and with the required cost savings.</p>Metrology: Statistical Analysis of Measurement Uncertaintytag:medtechiq.ning.com,2020-02-17:2140535:BlogPost:2792192020-02-17T11:44:16.000ZAdam Fleminghttps://medtechiq.ning.com/profile/Compliance4all
<p>The webinar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and "uncertainty ratios".</p>
<p>Several of the standard methods for analyzing measurement variation are then described and explained, as derived from AIAG's Measurement System Analysis reference book. The methods include: Gage R&R (ANOVA method, for 3 gages, 3 persons, 3 replicates, and 10 parts), Gage Correlation (for 3 gages), Gage…</p>
<p>The webinar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and "uncertainty ratios".</p>
<p>Several of the standard methods for analyzing measurement variation are then described and explained, as derived from AIAG's Measurement System Analysis reference book. The methods include: Gage R&R (ANOVA method, for 3 gages, 3 persons, 3 replicates, and 10 parts), Gage Correlation (for 3 gages), Gage Linearity, and Gage Bias. The webinar ends with an explanation of how to combine all relevant uncertainty information into an "Uncertainty Budget" that helps determine the appropriate width of QC specification intervals (i.e., "guard-banded specifications"). Spreadsheets are used to demonstrate how to perform the methods described during the webinar.</p>Risk Management - Implementing ISO 14971: 2018tag:medtechiq.ning.com,2020-02-07:2140535:BlogPost:2734392020-02-07T10:55:53.000ZAdam Fleminghttps://medtechiq.ning.com/profile/Compliance4all
<p>One of the cornerstones of the safety standards such as ISO 14971 is risk management. The principles relating to risk management set out by these standards keep getting updated from time to time. Because of this, it is imperative for organizations that come under the purview of the ISO standards to implement and maintain safety standards that comply with the requirements set out by them.</p>
<p>ISO 14971’s 2019 update will be explained in a lucid manner at a webinar that is being organized…</p>
<p>One of the cornerstones of the safety standards such as ISO 14971 is risk management. The principles relating to risk management set out by these standards keep getting updated from time to time. Because of this, it is imperative for organizations that come under the purview of the ISO standards to implement and maintain safety standards that comply with the requirements set out by them.</p>
<p>ISO 14971’s 2019 update will be explained in a lucid manner at a webinar that is being organized by Compliance4All, a leading provider of professional training for the areas of regulatory compliance, on February 27.</p>Death by CAPA - Does your CAPA Program need a CAPA?tag:medtechiq.ning.com,2020-02-07:2140535:BlogPost:2733542020-02-07T10:54:53.000ZAdam Fleminghttps://medtechiq.ning.com/profile/Compliance4all
<p>Corrective and Preventive Action (CAPA) is the foundation of a robust Quality Management System (QMS). Building a compliant, effective, and solid CAPA process into the QMS is the only way by which a company's QMS can guarantee safe and effective products.</p>
<p>A weak CAPA process invites disastrous consequences like complaints, recalls, 483s, and Warning Letters. It is a fact that CAPA is one of the most frequently cited reasons by the FDA for issuing 483’s and Warning Letters. Moreover, a…</p>
<p>Corrective and Preventive Action (CAPA) is the foundation of a robust Quality Management System (QMS). Building a compliant, effective, and solid CAPA process into the QMS is the only way by which a company's QMS can guarantee safe and effective products.</p>
<p>A weak CAPA process invites disastrous consequences like complaints, recalls, 483s, and Warning Letters. It is a fact that CAPA is one of the most frequently cited reasons by the FDA for issuing 483’s and Warning Letters. Moreover, a CAPA into which all the processes have not been built is a drain on the company’s resources.</p>Death by CAPA - Does your CAPA Program need a CAPA?tag:medtechiq.ning.com,2020-02-07:2140535:BlogPost:2732582020-02-07T10:54:51.000ZAdam Fleminghttps://medtechiq.ning.com/profile/Compliance4all
<p>Corrective and Preventive Action (CAPA) is the foundation of a robust Quality Management System (QMS). Building a compliant, effective, and solid CAPA process into the QMS is the only way by which a company's QMS can guarantee safe and effective products.</p>
<p>A weak CAPA process invites disastrous consequences like complaints, recalls, 483s, and Warning Letters. It is a fact that CAPA is one of the most frequently cited reasons by the FDA for issuing 483’s and Warning Letters. Moreover, a…</p>
<p>Corrective and Preventive Action (CAPA) is the foundation of a robust Quality Management System (QMS). Building a compliant, effective, and solid CAPA process into the QMS is the only way by which a company's QMS can guarantee safe and effective products.</p>
<p>A weak CAPA process invites disastrous consequences like complaints, recalls, 483s, and Warning Letters. It is a fact that CAPA is one of the most frequently cited reasons by the FDA for issuing 483’s and Warning Letters. Moreover, a CAPA into which all the processes have not been built is a drain on the company’s resources.</p>Death by CAPA - Does your CAPA Program need a CAPA?tag:medtechiq.ning.com,2020-02-07:2140535:BlogPost:2735352020-02-07T10:54:49.000ZAdam Fleminghttps://medtechiq.ning.com/profile/Compliance4all
<p>Corrective and Preventive Action (CAPA) is the foundation of a robust Quality Management System (QMS). Building a compliant, effective, and solid CAPA process into the QMS is the only way by which a company's QMS can guarantee safe and effective products.</p>
<p>A weak CAPA process invites disastrous consequences like complaints, recalls, 483s, and Warning Letters. It is a fact that CAPA is one of the most frequently cited reasons by the FDA for issuing 483’s and Warning Letters. Moreover, a…</p>
<p>Corrective and Preventive Action (CAPA) is the foundation of a robust Quality Management System (QMS). Building a compliant, effective, and solid CAPA process into the QMS is the only way by which a company's QMS can guarantee safe and effective products.</p>
<p>A weak CAPA process invites disastrous consequences like complaints, recalls, 483s, and Warning Letters. It is a fact that CAPA is one of the most frequently cited reasons by the FDA for issuing 483’s and Warning Letters. Moreover, a CAPA into which all the processes have not been built is a drain on the company’s resources.</p>Process Capability Analysis by means of Confidence Reliability Calculationstag:medtechiq.ning.com,2020-02-07:2140535:BlogPost:2733522020-02-07T10:52:57.000ZAdam Fleminghttps://medtechiq.ning.com/profile/Compliance4all
<p>The webinar begins with a discussion of relevant regulatory requirements, as motivation for calculating "confidence/reliability". Then, some vocabulary and basic concepts are discussed.</p>
<p>Next, detailed descriptions are given for how to calculate confidence/reliability for data that is either pass/fail (i.e., "attribute" data), normally-distributed measurement data, non-normally distributed measurement data that can be transformed into normality, or non-normally distributed measurement…</p>
<p>The webinar begins with a discussion of relevant regulatory requirements, as motivation for calculating "confidence/reliability". Then, some vocabulary and basic concepts are discussed.</p>
<p>Next, detailed descriptions are given for how to calculate confidence/reliability for data that is either pass/fail (i.e., "attribute" data), normally-distributed measurement data, non-normally distributed measurement data that can be transformed into normality, or non-normally distributed measurement data that cannot be transformed into normality. Spreadsheets are shown as examples of how to implement the methods described in the webinar. A final discussion is provided on how to introduce the methods into a company.</p>Save Your Food Business!! - Business Continuity & Disaster Recoverytag:medtechiq.ning.com,2020-02-07:2140535:BlogPost:2735302020-02-07T10:51:49.000ZAdam Fleminghttps://medtechiq.ning.com/profile/Compliance4all
<p>Consumer Safety is paramount in the food industry, which an industry that is heavily regulated by domestic and international authorities such as the FDA, EPA etc.</p>
<p>Failing to maintain consumer safety in the food industry, is extremely costly both in human life and / or suffering and in terms of the costs for recalls, fines levied against the company responsible for the lapse in safety, and impact to the reputation of the company, which can become irrevocable.<br></br><br></br>While consumer…</p>
<p>Consumer Safety is paramount in the food industry, which an industry that is heavily regulated by domestic and international authorities such as the FDA, EPA etc.</p>
<p>Failing to maintain consumer safety in the food industry, is extremely costly both in human life and / or suffering and in terms of the costs for recalls, fines levied against the company responsible for the lapse in safety, and impact to the reputation of the company, which can become irrevocable.<br/><br/>While consumer safety can be impacted at any time, the possibility and magnitude of impact worsens exponentially, in the case of a natural or man-made disaster. Despite this, most companies are not set up to respond to disasters. This course will outline the issues that need to be considered in the preparing to respond to disasters, and will suggest ways to minimize impact to the business and to maintain consumer safety. The course will also outline ways to prevent such impact in the future.</p>Save Your Food Business!! - Business Continuity & Disaster Recoverytag:medtechiq.ning.com,2020-02-07:2140535:BlogPost:2732542020-02-07T10:51:48.000ZAdam Fleminghttps://medtechiq.ning.com/profile/Compliance4all
<p>Consumer Safety is paramount in the food industry, which an industry that is heavily regulated by domestic and international authorities such as the FDA, EPA etc.</p>
<p>Failing to maintain consumer safety in the food industry, is extremely costly both in human life and / or suffering and in terms of the costs for recalls, fines levied against the company responsible for the lapse in safety, and impact to the reputation of the company, which can become irrevocable.<br></br><br></br>While consumer…</p>
<p>Consumer Safety is paramount in the food industry, which an industry that is heavily regulated by domestic and international authorities such as the FDA, EPA etc.</p>
<p>Failing to maintain consumer safety in the food industry, is extremely costly both in human life and / or suffering and in terms of the costs for recalls, fines levied against the company responsible for the lapse in safety, and impact to the reputation of the company, which can become irrevocable.<br/><br/>While consumer safety can be impacted at any time, the possibility and magnitude of impact worsens exponentially, in the case of a natural or man-made disaster. Despite this, most companies are not set up to respond to disasters. This course will outline the issues that need to be considered in the preparing to respond to disasters, and will suggest ways to minimize impact to the business and to maintain consumer safety. The course will also outline ways to prevent such impact in the future.</p>Save Your Food Business!! - Business Continuity & Disaster Recoverytag:medtechiq.ning.com,2020-02-07:2140535:BlogPost:2735282020-02-07T10:51:46.000ZAdam Fleminghttps://medtechiq.ning.com/profile/Compliance4all
<p>Consumer Safety is paramount in the food industry, which an industry that is heavily regulated by domestic and international authorities such as the FDA, EPA etc.</p>
<p>Failing to maintain consumer safety in the food industry, is extremely costly both in human life and / or suffering and in terms of the costs for recalls, fines levied against the company responsible for the lapse in safety, and impact to the reputation of the company, which can become irrevocable.<br></br><br></br>While consumer…</p>
<p>Consumer Safety is paramount in the food industry, which an industry that is heavily regulated by domestic and international authorities such as the FDA, EPA etc.</p>
<p>Failing to maintain consumer safety in the food industry, is extremely costly both in human life and / or suffering and in terms of the costs for recalls, fines levied against the company responsible for the lapse in safety, and impact to the reputation of the company, which can become irrevocable.<br/><br/>While consumer safety can be impacted at any time, the possibility and magnitude of impact worsens exponentially, in the case of a natural or man-made disaster. Despite this, most companies are not set up to respond to disasters. This course will outline the issues that need to be considered in the preparing to respond to disasters, and will suggest ways to minimize impact to the business and to maintain consumer safety. The course will also outline ways to prevent such impact in the future.</p>Pharmaceutical Drug Registration in Chinatag:medtechiq.ning.com,2019-10-09:2140535:BlogPost:2009522019-10-09T11:29:48.000ZAdam Fleminghttps://medtechiq.ning.com/profile/Compliance4all
<div class="post-thumbnail"></div>
<div class="entry-content"><p>Surely, no pharma company can overlook the world’s second largest pharmaceutical market: China. Its huge population has a high demand for healthcare products. In tune with this growing requirement, many changes have been brought in into the healthcare system, which is now more attractive than ever to foreign companies that want to bring in new products to market.</p>
<p>On the one hand, factors such as incentives, such as market…</p>
</div>
<div class="post-thumbnail"></div>
<div class="entry-content"><p>Surely, no pharma company can overlook the world’s second largest pharmaceutical market: China. Its huge population has a high demand for healthcare products. In tune with this growing requirement, many changes have been brought in into the healthcare system, which is now more attractive than ever to foreign companies that want to bring in new products to market.</p>
<p>On the one hand, factors such as incentives, such as market exclusivity and acceptance of foreign clinical trial data, are too good to be missed. On the other, foreign pharmaceutical companies also need to be aware of the highly regulated nature of this market.</p>
<p>Yingying Liu, a senior consultant who works for Michor Consulting, will be the speaker at this webinar. Commercial Managers, Regulatory Affairs Professionals and Operations Managers who want to benefit from this learning can enroll for this webinar by visiting <a href="https://www.compliance4all.com/control/w_product/~product_id=502758LIVE">https://www.compliance4all.com/control/w_product/~product_id=502758LIVE</a></p>
<hr/><p><img class="alignnone size-full wp-image-2830 below-entry-meta" src="https://compliance4all14.files.wordpress.com/2019/10/istock-174825736-webbanner.jpg?w=840" alt="istock-174825736-webbanner"/>https://compliance4all14.files.wordpress.com/2019/10/istock-174825736-webbanner.jpg?w=1680 1680w, <a href="https://compliance4all14.files.wordpress.com/2019/10/istock-174825736-webbanner.jpg?w=150">https://compliance4all14.files.wordpress.com/2019/10/istock-174825736-webbanner.jpg?w=150</a> 150w, <a href="https://compliance4all14.files.wordpress.com/2019/10/istock-174825736-webbanner.jpg?w=300">https://compliance4all14.files.wordpress.com/2019/10/istock-174825736-webbanner.jpg?w=300</a> 300w, <a href="https://compliance4all14.files.wordpress.com/2019/10/istock-174825736-webbanner.jpg?w=768">https://compliance4all14.files.wordpress.com/2019/10/istock-174825736-webbanner.jpg?w=768</a> 768w, <a href="https://compliance4all14.files.wordpress.com/2019/10/istock-174825736-webbanner.jpg?w=1024">https://compliance4all14.files.wordpress.com/2019/10/istock-174825736-webbanner.jpg?w=1024</a> 1024w" sizes="(max-width: 709px) 85vw, (max-width: 909px) 67vw, (max-width: 1362px) 62vw, 840px" /></p>
<p>The Chinese regulatory body, formerly CFDA, and now renamed as CNDA, has introduced a series of significant recent changes to the marketing authorization regulations with its large number of guidelines and opinions (in Chinese). At this webinar, Ms. Liu will:</p>
<ul>
<li>Summarize the key changes in the legislation</li>
<li>Provide the new procedures for the marketing authorization application processes in China</li>
<li>Highlight the key steps during the marketing authorization procedure</li>
<li>Will address specific issues, such as:<ul>
<li>sample testing</li>
<li>bundling review for API, excipients and packaging material</li>
<li>priority review and accelerated approval</li>
</ul>
</li>
<li>Suggest best practices when interacting with the regulatory authorities, such as the Center of Drug Evaluation (CDE) or the testing agency</li>
<li>Provide an opportunity to ask very specific questions about the NDA process for any type of drugs</li>
</ul>
<p>————————————————————————————————————–</p>
<p><strong>About the expert</strong>: Yingying Liu is an experienced Regulatory Affairs professional with a background in pharmaceutical science and technology. Yingying has worked on local and global projects for various blue-chip healthcare companies in China. She assisted a wide range of global clients obtaining clinical trial authorizations and bringing their products to market in China, and provided regulatory consultation to clients interested in registering or importing drugs or devices into China. In particular, she helped facilitate meetings and interactions with the China regulatory authorities.</p>
<p>Rregistration in china for full concept <a href="https://t2m.io/8jfdn67X">https://t2m.io/8jfdn67X</a></p>
</div>Facts about deviation investigations everyone should knowtag:medtechiq.ning.com,2019-08-12:2140535:BlogPost:1657202019-08-12T12:35:23.000ZAdam Fleminghttps://medtechiq.ning.com/profile/Compliance4all
<div class="post-thumbnail"></div>
<div class="entry-content"><p>Focus on how to avoid the pitfalls that may occur during FDA inspections and help eliminate 483 observations. Learn how to identify and avoid potential pitfalls during deviation investigations.</p>
<p>One of the foremost common authority 483 and Warning Letter citations continues to be inadequate investigations. The authority uses the investigation reports and investigation trends to spot potential quality issues altogether areas…</p>
</div>
<div class="post-thumbnail"></div>
<div class="entry-content"><p>Focus on how to avoid the pitfalls that may occur during FDA inspections and help eliminate 483 observations. Learn how to identify and avoid potential pitfalls during deviation investigations.</p>
<p>One of the foremost common authority 483 and Warning Letter citations continues to be inadequate investigations. The authority uses the investigation reports and investigation trends to spot potential quality issues altogether areas of the corporate. Ultimately, inadequate investigations will result in 483 citations, Warning Letters, unharness of sub-standard product, or product recall. what is more, pricey and long system rectification is also needed.</p>
<p><img class=" wp-image-2765 aligncenter" src="https://compliance4all14.files.wordpress.com/2019/08/avoid-the-pitfalls-300x169.png?w=351&h=198" alt="avoid-the-pitfalls-300x169"/>https://compliance4all14.files.wordpress.com/2019/08/avoid-the-pitfalls-300x169.png?w=150&h=85 150w" sizes="(max-width: 351px) 85vw, 351px" width="351" height="198" /><br/> Having a procedure on Deviation Investigations isn’t enough. it’s the content and conclusions of the investigations themselves that really count. Doing a correct root cause analysis, gathering proof and guaranteeing a property corrective action is vital to a correct deviation investigation.</p>
<p>This Session can facilitate attendees perceive the elemental investigation steps and ability sets. Key focus are placed on identification and initial news of deviations, fact/evidence gathering, and incoming at the right root cause and CAPA. The importance of investigation coming up with, vital thinking skills and effective preventative action plans will be mentioned.</p>
<p>Who will be benefit:</p>
<ul>
<li>Deviation Investigators</li>
<li>Reviewers and Approvers of Deviation Investigations</li>
<li>QA Staff and Management</li>
<li>Regulatory Affairs Staff and Management</li>
<li>QC staff and Management</li>
<li>Compliance Auditors</li>
</ul>
<p><strong>About the Instructor:</strong></p>
<p><b>Danielle DeLucy</b> MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 17 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations.</p>
<p><a href="https://t2m.io/tCmk8fXw">Read here more</a></p>
</div>FOOD SUPPLY CHAIN – An Incredibly Easy Method That Works For Alltag:medtechiq.ning.com,2019-05-16:2140535:BlogPost:1135822019-05-16T11:05:15.000ZAdam Fleminghttps://medtechiq.ning.com/profile/Compliance4all
<div class="post-thumbnail"></div>
<div class="entry-content"><p>A few sciences are changing our lives in more ways than we could have imagined a few decades ago. Artificial Intelligence (AI) is at the forefront of these. Although a few decades old, it has received a huge boost of late with the emergence of the cloud, which is set to help it overcome one of its biggest stumbling blocks, namely space, the added power of computing, and wider methods of algorithms.</p>
<p>While one would like to…</p>
</div>
<div class="post-thumbnail"></div>
<div class="entry-content"><p>A few sciences are changing our lives in more ways than we could have imagined a few decades ago. Artificial Intelligence (AI) is at the forefront of these. Although a few decades old, it has received a huge boost of late with the emergence of the cloud, which is set to help it overcome one of its biggest stumbling blocks, namely space, the added power of computing, and wider methods of algorithms.</p>
<p>While one would like to associate AI with robotics, this is taking a very limited view of a topic that has unimaginable potency. Food supply is one of the areas in which AI can make dramatic changes. The areas of the <a href="https://www.compliance4all.com/control/w_product/~product_id=500660REC">food supply chain</a> in which AI can make terrific changes for the better include:</p>
<ul>
<li>Robotic planting</li>
<li>Harvesting systems through self-driving trucks</li>
<li>Inspection systems</li>
<li>Traceability</li>
<li>Robotic pick and place loading systems</li>
<li>Robotic grading systems</li>
<li>Food processing systems</li>
<li>Pick and place</li>
<li>Inventory control and other related areas.</li>
</ul>
<p>Given that world of opportunities that could open up with AI in the food supply chain, it makes a lot of sense to learn about these in detail under expert guidance. This is what a webinar from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, is offering.</p>
<p>Compliance4All brings the highly illustrious, senior Quality System professional, John Ryan, as the speaker of this 90-minute session on AI in the food supply chain, which will be organized on April 29. To gain valuable insights into how AI can impact the food supply chain and make a lasting improvement in that area, please register for this webinar by visiting <a href="https://t2m.io/PzUP4prE" target="_blank" rel="noopener">https://t2m.io/PzUP4prE</a></p>
<p>————————————————————————————————————-</p>
<p>The aim of this webinar on the topic of AI in the food supply chain is to shed light on how AI can seriously impact a company by bringing about customer driven cost reductions and improvements in food safety and quality or delivery through-put times.</p>
<p>Dr. Ryan will review some of the current trends and products that are emerging on the horizon and will make a strong impact on companies, irrespective of which part of the food supply chain they work in. He will offer an explanation of the basic AI concepts and will discuss how a few giant companies are working together to bring AI to the food supply chain. He will also explain the various currently available systems and describe some of the technologies and companies driving this massive movement.</p>
<p>Participants of this session on AI in the food supply chain will take home the following objectives:</p>
<ul>
<li>Understand basic AI concepts</li>
<li>Learn about some of the players and how they are planning and working together</li>
<li>Review currently available AI food supply chain solutions</li>
<li>Take a look into future AI products and solutions</li>
<li>Understand who is investing in what and why</li>
<li>Understand the potentials for success and failure.</li>
</ul>
<p>Aimed at benefiting professionals such as CEOs, VPs and Directors in food supply companies, food processors, retailers, transporters, distributors and restaurant chains, IT personnel in food suppliers, food safety and Quality Specialists, Compliance Officers, transportation managers and marketing personnel, this webinar on Artificial Intelligence in the food supply chain will cover the following areas:</p>
<ul>
<li>Basics of AI</li>
<li>What players are involved and why</li>
<li>Different food supply chain segments impacted</li>
<li>How close is AI to us today?</li>
<li>Key software integration requirements.</li>
</ul>
<p>————————————————————————————————————–</p>
<p><strong>About the speaker</strong>: Dr. Ryan has worked and lived extensively throughout Asia and the U.S. at the corporate and facility levels for large and small companies as a turnaround specialist. He designed and piloted the US’ first RFID enabled farm to retail traceability system in the nation while working for a reputed company previously. His company, Ryan Systems, works with some of the world’s leading equipment, hardware, software, training and integration companies in the business.</p>
<p>He has published over forty papers on Quality Systems and has recently published a book for Elsevier Press entitled, <em>Guide to Food Safety and Quality During Transportation: Controls, Standards and Practices</em>. He previously published <em>The Quality Team Concept in Total Quality Control</em> with the American Society for Quality.</p>
</div>