Major CGMP Issues - US FDA Concerns in 2022

Why Should You Attend:

A review of recent US FDA Inspectional Observations / FDA Form 483 Observations, as well as FDA statements and actions, indicate the major areas of regulatory concern. The past is no indicator of present or future concerns. The Agency uses publicized high-profile cases to drive compliance in the regulated industries. Certain CGMP areas, e.g., CAPA, are receiving increased scrutiny. "Risk-based" (patient risk) is another. Failure to correct problems leads to Warning Letters or more severe regulatory actions. Requirement for "better science" must be evident in compliance. "Business as usual" is never acceptable, but do some of a company’s documents reflect that outdated thinking. Also changes from the EU, MDD to MDR, ISO 13485:2016 ... confusion over what is "Risk". Don't be caught off guard by these major shifts in emphasis. Refine internal audits and get your company prepared to address the FDA's most recent requirements both in the US and outside.

This tougher emphasis also affects clinical trial expectations, product submissions and company response requirements. This change has a major impact on individual compliance objectives, efforts and measurements of success. The definition of "Risk" in systems and documentation can make the difference in a "Pass" or "Fail" regulatory inspection.

Areas Covered in the Webinar:

• Recent industry trends, bad and good
• The FDA’s Strategic Priorities
• Major foreseeable problem areas for 2022 onward - The "Heavy Hitters"
• A company gap analysis
• Correcting problem-prone areas
• Avoid complacency from past “good” audits
• The Most Frequent / Serious 483’s – 483’s that generate Warning Letters
• The risk-based phased approach – what does that mean
• Prove “State of Control”
• Entropy - a major "player"

Who Will Benefit:

• Senior Management
• Regulatory Affairs
• Quality Assurance
• Production
• R&D and Engineering
• All personnel involved in a U.S. FDA-regulated environment especially those involved in new product development, line extensions, and incremental product improvements, having to evaluate those changes to existing FDA-cleared 510(K)'s, and then document their decisions in harmony with regulations.

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 40 years experience in U.S. FDA-regulated industries, 26 as an independent consultant. John has worked with companies from start-up to Fortune 100, world wide. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, submissions, process / product / equipment including QMS and software validations, ISO 14971 product risk management and human factors files / reports, Design History Files, Technical documentation. He's held positions in Engineering, QA, QAE, RA, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles and book chapters (RAPS) in peer reviewed journals, conducted workshops and webinars worldwide. John is a graduate of UCLA.

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