Annual Current Good Manufacturing Practices (cGMP) Training

  • Kelly Thomas
  • 6, December 2022 Tuesday
  • 10:00 AM PST | 01:00 PM EST (60 Min)

This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.

Live Online Training
December 06, Tuesday 10:00 AM PST | 01:00 PM EST (60 Min)

$199.00
One Dial-in One Attendee
$899.00
Group-Max. 10 Attendees/Location
(For multiple locations contact Customer Care)

Recorded Version Only

(PPT + Recorded Streaming Link)

$249.00
1x Person - Unlimited viewing for 6 Months (For multiple locations contact Customer Care)
rec Recorded Link and Ref. material will be available in My Account Section 48 hrs after completion of Live training

Download File Only

(PPT + Recorded Training File)

$349.00
Downloadable file is for usage in one location only.
(For multiple locations contact Customer Care)
Downloadable link along with the materials will be emailed within 2 business days after completion of Live training
Customer Care

Fax: +1-650-362-2367

Email: customercare@fdatrainingalert.com

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Why Should You Attend:

Good Manufacturing Practice regulations, which have the force of law, require that manufacturers, processors, and packagers of medicinal products take proactive steps to ensure that their products are safe, pure, and effective. cGMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors.

Personnel involved in cGMP must have documented training of current Good Manufacturing Practices (cGMP) training. This webinar will focus on the FDC Act and 21CFR federal regulations as applied to cGMP and provide an overview of the US FDA regulations for compliance.

Areas Covered in the Webinar:
  • What is cGMP and why is it important; Brief history of drug manufacturing
  • Describe the federal regulations applied to cGMP and inspections
  • Discuss: Organization and Personnel, Building and Facilities, Equipment, Production and Process control, Laboratory, Quality, Documentation
  • Review listing of guidelines as apply to cGMP
  • Terms and Definitions
Who Will Benefit:

This webinar will be beneficial for all personnel involved in the manufacturing, packaging, labeling, storage, testing, and distributing of medicinal products in US. Personnel in the following roles can especially benefit from the presentation:

  • Quality and Compliance
  • Manufacturing and Packaging
  • IT
  • Operations
  • R&D
  • Equipment, Facilities and Process Engineering Documentation
Instructor Profile:
Kelly Thomas Kelly Thomas

Vice President, Americas Quality Operations at Stallergenes Greer

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

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. FDATrainingAlert 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@fdatrainingalert.com call +1-888-771-6965 (Toll Free).

Product Reviews

Write review

Very useful and informative about cGMP and current state of art.
- Jael Galli

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