Live Webinar
on
U.S. FDA's Strategic Priorities for 2012 and Beyond
Date & Time: Wednesday, January 11, 2012
10:00 AM PST | 01:00 PM EST
Duration: 90 Minutes
Instructor: John E Lincoln
Location: Online
Price : $245.00
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(for one participant)
Instructor Profile:
Overview:
John E Lincoln Consultant, Medical Device and Regulatory Affairs
This webinar will examine the FDA's recently instituted annual "Strategic Priorities" initiative, with emphasis on 2012. Such a review will focus on the broad range of issues a company's senior management and QA/RA need to consider in their annual Management Review of their existing quality management system. This review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what the FDA and industry need to do internally. An additional review of recent information from the Agency, other goals of the Agency that have already been translated into action in the past year will provide direction in areas of concern and what to expect in the future.
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Mandated Areas for Annual Reviews The FDA's "Strategic Priorities" for 2012 and Beyond Tougher Regulatory Science -- What "Better Science" Really Means Device, Pharmaceutical and Biological Issues General CGMP Issues -- Strengthened Compliance FDA's Life Cycle View Requirements Safety / Integrity of Global Supply Chain Heightened Supplier Issues FDA Clearance / Approval Only the Beginning -- Product "Lifecycles"
Click here to register for this webinar
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 peerreviewed 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 FDAregulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA. ...more
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Who Will Benefit: l
Senior management in Drugs, Devices, Biologics, Dietary Supplements
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QA
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RA R&D
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Engineering Production Operations
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Consultants
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