All Blog Posts (1,472)

The aim of this webinar is to provide an introductory overview of the requirements demanded by the FDA and EMA (arguably the two most important regulatory authorities for drug developers) for EIM (the IND and IMPD) and to provide an brief review of where the agencies differ as well the commonalities of approach for their EIM dossiers.

Although each regulatory authority publishes guidelines and instructions regarding the requirements for the Entry Into Man (EIM) of a new…

Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, is organizing a webinar on the topic, “Complaint Handling” on February 6. Peggy J. Berry, President & CEO at Synergy Consulting, will be the speaker at this webinar.

Please visit http://bit.ly/2GFGiXr to enroll for this webinar.

—————————————————————————————————————

A complaint says a lot about a product. It helps the…

Preliminary risk assessment (e.g., Likelihood X Impact) and the results of previous audits (e.g., number of NCs) are often used to help prioritize the audit schedule. While these are worthwhile to consider, they do not necessarily reflect the real-time performance of the processes that could be included in the audit plan. This means many audits are likely investing time and human resources in looking at processes that are performing adequately, while others that might be at greater risk are…

Traininng.com, a leading provider of professional training for all the areas of regulatory compliance, is organizing a webinar on the topic, “Tax Evasion and Tax Fraud. What it means to you when monitoring BSA and filing SARs”.

Doug Keipper, a Certified Anti-Money Laundering Specialist (CAMS) and a former Bank Secrecy Act officer and compliance officer, will be the speaker at this webinar. Please visit…

Traininng.com, a reliable provider of professional training for the areas of regulatory compliance, will organize a webinar on the topic, “Rolling Forecasts: The New Way to Budget”, on February 11. The speaker at this 75-minute session is Carl Young, a senior finance and business professional.

Please visit…

Compliance4All, a leading provider of professional training for all areas of regulatory compliance, is organizing a 90-minute webinar on the topic, “Dietary Supplements CGMPS – 21 CFR 111 Compliance”, on February 5. John E. Lincoln, a medical device and Regulatory Affairs consultant, will be the expert at this webinar.

Please visit http://bit.ly/2DIk8lf to enroll for this webinar.

————————————————————————————————————-

How to find the…

How to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows:

• ISO standards and FDA/MDD regulations regarding the use of statistics.
• Basic vocabulary and concepts, including distributions such as binomial, hypergeometric, and Normal, and transformations into Normality.
• Statistical…

Quality Assurance, Quality Systems, quality risk management and Quality Control are the cornerstones of Good Manufacturing Practices (GMP). Being a globally acclaimed provider of training courses for professionals, Traininng.com introduces these concepts at this online regulatory compliance training webinar.

The expert, Dr Madeleine S. Fairweather, will present these concepts in accordance with EU GMP Part II. However,…

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies.  Reformatting for multiple submissions is substantially limited.  The CTD has improved the regulatory review processes and enabled implementation of good review…

Technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this webinar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.

After setting the stage for this content, we delve into the writing process beginning with the audience and how the…

If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are…

The complexity and vulnerability of software is expanding exponentially, so fast that Congress removed some device software from FDA’s jurisdiction.  The remaining software regulated by FDA presents a degree of a risk to health that creates a public health concern.  Part of that risk involves the intentional activity that can conflict, intrude or destroy software.  The problems are taking center stage in the “healthcare software” dialogue.  What issues can compromise or defeat the…

FDA Commissioner, Scott Gottlieb, has announced a major overhaul of the FDA’s update to the Nutrition Facts label on products. This overhaul, the first in nearly twenty years, is aimed at empowering consumers by furnishing information on Nutrition Facts labels pure maple syrup and honey that ensures greater accuracy and is more science-based. With this, the FDA wants to help consumers make more informed and healthier choices.

This update to the Nutrition Facts label has incorporated…

One errant email or text message can cost you tens of thousands of dollars in HIPAA fines and penalties and it doesn't matter who you're communicating with: patients, staff, providers or with insurance carriers.

A violation is a violation. And if you think it couldn't happen to you, think again. Text and email HIPAA violations are not always caused by what you might think. For example, you may think you are safe as long as you don't text patients - you're wrong.…

Process Validation (PV), according to the FDA, is collecting and assessing data right from the design stage till the production stage. PV is set out for all the stages of production for a product in the FDA-regulated industries. The core purpose of PV is to establish scientific proof that any process being employed has the capability of delivering quality products consistently.

The FDA’s process validation requirements are set out in its general principles of Process Validation.…

If you work with data, you’re likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources. Luckily there are two Microsoft tools- PowerPivot and PowerQuery-that solve ALL of these issues, right inside Excel.

In today’s world, there is tons of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful…

How practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2019.

The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information regarding the do's and don'ts with HIPAA - I want to add clarity for compliance officers and what you guys…

This is how the current-day situation of administering medical care runs: in the event of a medical need, the patient or someone attached to her is expected to sense the difficulty and call up the medical center to which the patient is attached. Help arrives after this is done. The medical practitioner may come over and attend to the patient at her location if the situation permits. Or else, the ambulance has to be called. All this has to done during what is called the Golden Hour: the most…

ISO 13485:2016 describes a process approach to Quality Management Systems for Medical Devices.  This 6 -hour virtual seminar will help you to understand the process approach and develop an effective Quality Management System (QMS) for Medical Device Companies.  A well-structured QMS meets the requirements of the Quality System Regulations and is both effective and efficient.  The regulations require that manufacturers “establish and maintain a quality system that is appropriate for the…

A slew of updates to existing medical device and diagnostics (MD & D) regulations is on the cards. Medical device and diagnostics is a field that keeps changing every now and then. But what is different this time is that the industry is up against a series of updates, not just from one regulatory agency, but from a multitude of agencies and standards: FDA, EMA, ISO 13485 and ISO 11607, the last of which is about packaging for terminally sterilized medical devices.

Nature of…