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.
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:
- 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.
Course Provider
John E Lincoln,
