MEDICAL DEVICES 2011 - Recent Major Industry CGMP Failures - Webinar By ComplianceOnline

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Category Medical Devices,conference,event,Webinar

Deadline: April 05, 2011 | Date: April 05, 2011

Venue/Country: Palo Alto, U.S.A

Updated: 2011-02-02 18:27:09 (GMT+9)

Call For Papers - CFP

The last year has 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. 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. Attend this webinar to learn 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? .

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