The Most Serious FDA 483s – How to Avoid them

If recent FDA audits are any indicator, it is that the FDA is making a shift in the way it views the most serious Form 483 observations. This makes an understanding of the changed focus arising out of the recent FDA audits on the part of this agency a matter of mandatory learning for companies that are subject to FDA regulations.

This crucial learning on the most serious FDA 483s and how to avoid them will be imparted at a 90-minute webinar from Compliance4All, a leading provider of professional learning for all the areas of regulatory compliance. At this session, which is on April 23, John E. Lincoln, a very senior medical device and regulatory affairs consultant, will be the speaker.

Please enroll for this valuable learning session by visiting https://www.compliance4all.com

• At this webinar on the most serious FDA 483s – how to avoid them, the speaker will use examples from recent top 483 findings to help participants evaluate the chief areas of FDA cGMP compliance audits and get a grasp of the agency’s audit "paradigm". These examples will form the basis for a comprehension of the actual and anticipated changes in emphasis in the FDA’s approach. This will help them to prepare better for a company’s internal audit program.

The aim of this session on the most serious FDA 483s – how to avoid them, is to help participating companies evaluate/perform a gap analysis, and then put in place the necessary fixes to ensure continuing compliance.

This session is of immense importance and value to personnel/companies in the pharmaceutical, medical device, diagnostic, nutraceutical and biologics fields. All personnel involved in an FDA-regulated environment, especially those involved in the areas of complaint handling, non-conforming material, out-of-specification, failure investigations, root cause analysis, labeling, distribution, storage, tracking, use or regulated medical products, will gain in a huge manner from this session.

The employees in the following areas in particular will benefit from this webinar: Senior Management, Regulatory Affairs, Quality Assurance, Production, and Engineering.

• p>

About the speaker: As a seasoned medical device and regulatory affairs consultant, John E. Lincoln has helped companies to implement or modify their GMP systems and procedures, product risk management, and FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and have been described in peer-reviewed technical articles, and workshops, worldwide.

During his more than 28 years of experience in the FDA-regulated medical products industry, John has also managed pilot production, Regulatory Affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and several projects, working in companies of sizes ranging from startups to Fortune 100.

Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations.