The Most Serious FDA 483s - How to Avoid Them

Why Should You Attend:

Recent FDA audits indicate a shift in the top serious Form 483 observations.

This webinar will evaluate the chief areas of FDA CGMP compliance audits based on recent top 483 findings to see actual and anticipated changes in emphasis, and how to better prepare with a company's internal audit program .

This 90-minute session will provide valuable assistance to all regulated companies in evaluating their existing compliance and internal audit emphasis in light of the changed FDA focus based on recent 483 analysis, and their audit "paradigm". Such analysis allows a company to evaluate/ perform a gap analysis, and then put in place the necessary fixes to ensure continuing compliance.

Areas Covered in the Webinar:

• Recent Most Serious FDA 483s
• The "Whys"
• Root Causes
• Avoid complacency from past "good" FDA audits.
• Shifting focus
• Maximize scarce resources
• The "risk-based" phased approach
• Maintain "the edge" -- fight "entropy"

Who Will Benefit:

This webinar applies to personnel/ companies in the Pharmaceutical, Medical Device, Diagnostic, Nutraceutical and Biologics fields. The employees who will benefit include:

• Senior management
• Regulatory Affairs
• Quality Assurance
• Production
• Engineering

All personnel involved in a U.S. FDA-regulated environment. Especially those involved in the complaing handling, non-conforming material, out-of-specification, failure investigations, root cause analysis, labeling, distribution, storage, tracking, use or regulated medical products.

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln is principal of J. E. Lincoln and Associates LLC, a consulting company with over 31 years’ experience in U.S. FDA-regulated industries, and 17 years as a full-time consultant. Mr. Lincoln has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, design control / design history files, and technical files. He's held positions in manufacturing engineering, QA, QAE, regulatory affairs, to the level of director and VP (R&D). In addition, Mr. Lincoln has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. Mr. Lincoln is a graduate of UCLA.

Topic Background:

There has been a major shift in the emphasis of U.S. FDA CGMP compliance audits, and the resulting FDA Form 483 Observations. This change in focus has a major impact on individual compliance objectives, efforts and measurements of success. The Agency has come under increasing negative publicity due to major publicized product failures / recalls, leading to public concern over insufficient oversite of new product introductions (and grandfathered product) by means of the 510(k) system. This affects the Agency's approach to audits and their expectations for companies.

Follow us :