Webinar Duration: 60 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

OVERVIEW:
This webinar will examine the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and its 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; the negative role of "entropy", and proactive and reactive Warning Letter avoidance techniques.

Why you should attend: The last few years have seen several major "names" in drugs and devices stumble over cGMP issues, resulting in recalls, lawsuits, and even possible criminal prosecution. 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. This change in focus has a major impact on interpretation of individual compliance objectives, cGMP objectives, and measurements of success. Recent negative publicity on pharmaceuticals, devices, as well as events in unrelated industries has put pressure on the Agency to "get tough on compliance / enforcement". The public wants change. The U.S. FDA is responding. The cGMP compliance audit, validations, 510(k) submissions / data, "better science", lifecycles, closed-loop CAPA, outsourcing / globalization and supply chain / control issues, and senior management, are all under more intense scrutiny.

Areas Covered In the Session:
- The Changed / Tougher FDA.
- Shifting and New Emphasis
- Core Expectations
- QSIT and Q10 Focus; and Q8 and Q9 "Lessons"
- High Risk Areas
-The Supply Chain
- The Multi-Site Challenge
- What Constitutes "Proof"
- Addressing the On-site Audit, the 483s, the Remediation / Responses

Who will benefit:
- Senior Management in Drugs, Devices, Biologics, Dietary Supplements
- QA
- RA
- R&D
- Engineering
- Production
- Operations

SPEAKER PROFILE:
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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