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.

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Sep-2016

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367

Email: customercare@complianceonline.com

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. 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 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.

Follow us :
Medical Device Recall Management
Managing Your Complaints and Obstacles in Post-Market Requirements

Refund Policy

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.

If you have any concern about the content of the webinar and not satisfied 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 customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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