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Effective Annual U.S. FDA CGMP Training
This FDA Compliance training 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.
Description
The majority of U.S. regulated companines have an annual CGMP training program. Many are inadequate. Some are taught by HR personnel unfamiliar with the CFR requirements. Sould 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 to 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. Attendees 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 seminar:
- Elements of CGMP Training.
- Management involvement / support.
- Basic / required topics.
- Use your Product Risk Management Files / Reports.
- Defect recognition, a key FDA requirement.
- Use CAPA data.
- Use P&PC systems data.
- Add training effectiveness to an existing Internal Audit Program;
- Training and the periodic Management Review;
- Periodic Training benefits to the "bottom line".
Who will benefit:
- Senior management, project leaders
- Regulatory affairs
- Quality systems personnel
- R&D and engineering staff
- All charged with or involved in material stream management, from ordering, procurement, manufacturing, through disposal.
- CAPA and P&PC personnel desiring to reduce or redirect remediation costs without sacrificing product safety and/or warranty costs.
Instructor Profile:
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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