Why Should You Attend:
The majority of U.S.-regulated companies have an annual CGMP training program. Many are inadequate. Some are taught by HR personnel unfamiliar with the CFR requirements. Should consultants be involved, and if so, how can they be best utilized, i.e., get rid of their formulaic approaches. How can a company compliant with the U.S. FDA’s QS Regulation, 21 CFR 820 (or 210, 211, et al) develop an effective training program? Inclusion of defect recognition. What are appropriate refresher subjects for inclusion? Different intervals to assure “annual” compliance. You will be helped to see how to develop, maintain and improve on a compliant CGMP Employee Training Program for their particular company, product line, and culture.
Areas Covered in the Webinar:
Who Will Benefit:
John E. Lincoln, consultant, has successfully designed, written over 50 ISO 14971-compliant Risk Management Files / Reports, including FMECA and FTA analysis, many in response to FDA 483 observation, which have subsequently passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development / design control projects; with over 24 years of experience, primarily in the medical device industry – working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco / Mallinckrodt. John serves on the Reader and Editorial Review Boards of MDDI Magazine and the Journal of cGMP.
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