Recent Major Industry CGMP Failures - Lessons Learned

Why Should You Attend:

The last year has seen several major "names" in drugs and devices stumble over cGMP issues, resulting in recalls, lawsuits, and even possible criminal prosecution. Other recent drug recalls are resulting in several class action lawsuits. A growing push by the Agency to get tougher and strengthen enforcement is one result. Bad publicity affecting once stellar names in the regulated industry is another. Public outcry for a more proactive FDA is yet another. Current FDA oversight methods are claimed to not be providing the product safety or efficacy seemingly promised. What has led to this situation? What can companies do proactively to address these concerns and better ensure better regulatory compliance?

Such high-profile field problems indicate that issues such as senior management involvement, product risk management, validation and change control and similar requirements are somehow being short-circuited. Attend this webinar to learn what can companies do in addressing these issues? Why is "entropy" a major player? How can a company "put an auditor's mind at ease" before, during and after a CGMP compliance audit? .

U. S. FDA-regulated companies are responsible for understanding current Good Manufacturing Practices as defined in the Code of Federal Regulations ( 21 CFR Part 111, 210/211, and 820). They are then required to translate those regulations into procedures and work instructions. Many companies who have successfully done that in the past are now failing audits, facing major recall, and multi-million dollar fines. What failures in the GMPs have led to this? What assumptions have proven to be invalid? What are the key areas of non-compliance? What can be done in a company to look for, validate or correct to prevent it from being the next news headline or "60 Minutes" feature? What new concerns need to be addressed now? How can companies make such determinations? What approaches are now mandated? How does ICH Q9 or ISO 14971 Risk Management fit into the process? How to maximize any remedial action process against scarce resources? .

This 90-minute webinar will answer all the above.

Areas Covered in the Seminar:

• The "tougher" U. S. FDA.
• Recent news headlines - prominent / respected company failures.
• What's behind the headlines.
• The "Heavy Hitters" problem areas.
• Reviewing a company's compliance to these findings.
• Correcting problem-prone areas.
• Entropy - a major "player".

Who Will Benefit:

• Senior management
• Regulatory affairs
• Quality Assurance
• Production
• Engineering & R&D
• 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.

Instructor Profile:

John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 29 years experience in U.S. FDA-regulated industries. John 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 so+E6ftware validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, 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 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. John is a graduate of UCLA.

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