Live Webinar
on
Meeting Annual U.S. FDA cGMP Training Requirements
Date & Time: Wednesday, October 5, 2011
10:00 AM PDT | 01:00 PM EDT
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,
There is an on-going major shift in the emphasis of U.S. FDA CGMP compliance audits. These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success.
Why should you attend: The FDA says it's getting tougher. Recent audits and other enforcement actions indicate that's true. The past ways of doing things is not acceptable. The Agency continues to use high-profile cases to drive compliance to smaller companies and suppliers.
Areas Covered in the Session:
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Focus on key cGMP issues
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Avoid complacency from past "good" FDA / ISO compliance Developing the Annual Lesson Plan(s) The major 21 CFR issues in 111, 210 / 211, and 820 Defect recognition How to address known problem areas during cGMP training Stop unauthorized changes -- Prove 'in control' Monitor and maintain 'the edge'
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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. ...more
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Who Will Benefit: l
Senior management in Drugs, Devices, Biologics, Dietary Supplements
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QA RA
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R&D Engineering Production Operations Consultants; others tasked with project leadership 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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