Effective Annual U.S. FDA CGMP Training


Instructor: John E Lincoln
Product ID: 701136

  • Duration: 60 Min
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.
Last Recorded Date: Sep-2016


$179.00 $249.00 (28%)SAVE: $70.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)



Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions


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.

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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Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).




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