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The Annual Meeting program is subject to change. Speakers are added as confirmations are received.
Please  note that Quality College workshops require separate registration.

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Sunday, April 8 • 8:00am - 5:00pm
Workshop 5 - GMP 101: Basic Training: History and Intro of US FDA GMPs (1 day)

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RQAP re-registration units: 2 non-GCP, non-GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Description
This course provides a history of the GMP regulations, what is the purpose, why were they created, how did they develop over time and an overview of the sections of the regulations.

Objectives
At the end of the course, the participants shall be able to: 
  • Understand the purpose of the GMP regulations.
  • How the regulations developed over time.
  • Provide an overview of the regulations.

Target Audience
Quality Assurance professionals and management looking for an overview of the GMP regulations.

Agenda
  • History and Introduction of the US FDA GMPs
  • Overview of 21CFR Parts 210 and 211
  • Out of Specifications
  • SOPs
  • QA versus QC
  • Review of Warning Letters

Speakers
MC

Megan Callan

Manager Regulatory Compliance, Charles River Laboratories
Megan Callan is the Manager of Regulatory Compliance at Charles River Laboratories. She is responsible for quality assurance required for GLP and GMP testing conducted at the Cleveland, OH site. She started her career working in microbiology laboratories for pharmaceutical/biotech... Read More →
avatar for Christine Garvey

Christine Garvey

Senior Manager, Regualtory Compliance, Charles River Laboratories, Inc
Christine Garvey is the Senior Manager of Regulatory Compliance at Charles River Laboratories. She is responsible for quality assurance required for GMP testing conducted at the Wilmington MA and Woburn MA sites. She started her career performing radiologic testing, transferring into... Read More →

Sunday April 8, 2018 8:00am - 5:00pm PDT
Platinum 8
  QC Workshop, QC Workshop - 1 Day

Attendees (2)