The U.S. FDA's New Global Engagement Initiative

Why Should You Attend:

The last two years have seen major initiatives at the FDA; as well as prominent drug and device failures over cGMP issues, resulting in recalls, lawsuits, class action lawsuits, and even possible criminal prosecution. The FDA sees globalization as a growing reality, and potential contributor of major regulatory issues: the supply chain, counterfeiting, clinical trials, other global outsourcing actions; by global / multinational corporations. A new paradigm for FDA guidance and strengthened enforcement is called for.

This 90-minute presentation will discuss what companies can do proactively to address these concerns and ensure better regulatory compliance from their global partners. You will learn how to translate FDA's current GMPs, as defined in the Code of Federal Regulations ( 21 CFR Part 111, 210/211, and 820), into procedures and work instructions and successfully implement them at off shore partners. We will also discuss failures in globalization and key areas of (cGMP) non-compliance. This webinar will evaluate the new FDA "Global Engagement" Initiative for new areas for heightened CGMP compliance.

Areas Covered in the Seminar:

• The U.S. FDA's New Global Engagement Initiatives.
• Recent global industry trends, bad and good.
• Major foreseeable problem areas.
• How the FDA initiatives impact regulated industries.
• Immediate actions to take.
• Long-term correction / preventive action of FDA-defined problem areas.

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.

Instructor Profile:

John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 30 years experience in U.S. FDA-regulated industries, 16 of which as head of his own consulting company. 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 software 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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