Avoiding Major Industry cGMP Failures – Recent Updates
Date & Time: Wednesday, November 30, 2011
10:00 AM PDT | 01:00 PM EDT
Duration: 90 Minutes
Instructor: John E Lincoln
Price : $245.00
(for one participant)
John E Lincoln Consultant, Medical device and Regulatory affairs,
U. S. FDA-regulated companies are responsible for understanding current Good Manufacturing Practices (cGMPs) 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.
Why should you 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. 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. Class action lawsuits. 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. 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. For most companies, the fixes are not rocketscience, but require a re-evaluation and re-emphasis of the "basics".
Areas Covered in the Session:
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
Suggest a Topic
Your Necessity is our Priority l
The "tougher" U. S. FDA and Regulatory “Hot Buttons”
Recent news headlines - prominent / respected company failures What's behind the headlines The "Heavy Hitters" problem areas
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Reviewing a company's compliance to these finding Correcting problem-prone areas Entropy - a major "player"
Click here to register for this webinar Who Will Benefit: l
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Senior management in Drugs, Devices, Biologics, Dietary Supplements QA RA R&D Engineering Production Operations Consultants; others tasked with product, process, validations, CGMP responsibilities
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar.
Best regards, Event-coordinator GlobalCompliancePanel
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