Recorded Webinar: The U.S. FDA's Tougher Supplier Controls

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Webinar Duration: 90 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: John E. Lincoln

This webinar will examine the stated intent of the Agency to get tougher in its expectations for the medical industry, their supply chain, and vendor compliance to the cGMPs.

It will examine how these goals of the Agency have translated into action over the past two plus years: The changing focus of QSIT re: medical devices, and ICH Q8, Q9, and Q10 re: pharmaceuticals; multi-site company operations, and the supply chain; Trends evident in 483 observations, Warning Letters, and recent major industry failures; Emphasis on proving a company is "in control" to an investigator's satisfaction regarding the integrity of its supply chain; and the negative role of "entropy". COA and COC, and vendor ranking models will be presented. The growing problem of counterfeiting and the drug pedigree will be discussed.

Why should you attend: The regulated medical products industry is increasingly a global industry, with extended supply chains. Recent headlines indicate major supplier problems caused by weak oversight of such sources. Poor cGMP by vendors has resulted in major recalls and class action lawsuits. As a result, there has been a major shift in the emphasis of the U.S. FDA cGMP compliance audit, also affecting clinical trial expectations, product submissions and company response requirements. The public wants change. The U.S. FDA is responding. This change in focus has a major impact on interpretation of individual compliance objectives, cGMP objectives, and measurements of success, with a major focus on the source, control, and documentation of raw materials, components, and even services. The cGMP compliance audit, 510(k) submissions / data, "better science", outsourcing / globalization and supply chain / control issues, and drug pedigrees, requests for offshore supplier information from domestic manufacturers, and new offshore U.S. FDA offices, reflect this growing concern. They are all part of a new, tougher stance on the supply chain by the U.S. FDA.

Areas Covered in the Session:
- The Globalization of the regulated Medical Products Industry
- The U.S. FDA's Shifting / New Emphasis
- Core Expectations
- QSIT and Q10 Focus; and Q8 and Q9 "Lessons"
- High Risk Areas
- The Supply Chain
- Ranking Schemes
- Pedigrees
- Entropy

Who Will Benefit:
- Senior management in Drugs, Devices, Biologics, Dietary Supplements
- QA
- RA
- R&D
- Engineering
- Production
- Operations

John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. 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 described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.

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