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Validity : 21st Apr'24 to 01st May'24
Effective Annual U.S. FDA CGMP Training
- 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"
Overview of the webinar
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.
Who should attend?
- 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
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. 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.
Faculty - Mr.John E. Lincoln
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 40 years experience in U.S. FDA-regulated industries, 27 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has ptublished numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.