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Live Webinar Change Control - Key to Successful cGMP Compliance Date: Tue, December 2, 2014 Instructor: John E Lincoln
Time: 10:00 AM PST | 01:00 PM EST
Duration: 60 Minutes
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Location: Online
Course "Change Control - Key to Successful cGMP Compliance" has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification upon full completion.
Overview: There is a continuing pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events in foods, drugs, and devices seem to support this perception. The "tougher" FDA is determined to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit.
Areas covered in the session: Change Control - what it is; what it is not Areas impacted by Change Control Regulatory / FDA 483 "Hot Buttons" Design Control and Filing a New 510(k) Document Control Identifying Changes Preventing Negative Changes and Entropy Give the FDA It's Desired 'State of Control' Business Needs and Obtaining Stakeholder 'Buy-In'
Who Will Benefit: Senior management in Drugs, Devices, Biologics, Dietary Supplements QA RA R&D Engineering Production Operations Consultants
About Speaker John E Lincoln Consultant, Medical device and Regulatory affairs, 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,
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