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.
DescriptionThis 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.
ObjectivesAt 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 AudienceQuality 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