Recent Major Industry CGMP Failures and How to Avoid Them - Webinar By GlobalCompliancePanel

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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. 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 rocket-science, but require a re-evaluation and re-emphasis of the "basics".

Areas Covered in the Session:
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
Reviewing a company's compliance to these finding
Correcting problem-prone areas
Entropy - a major "player"
Who Will Benefit:
Senior management in Drugs, Devices, Biologics, Dietary Supplements
QA
RA
R&D
Engineering
Production
Operations
Consultants