Key GMP Requirements of Pharmaceutical Laboratories – Understanding the Latest FDA & Global Regulatory Requirements

Pharmaceutical laboratories serve one of the most important functions in the manufacturing of drug products. Section I of 21 CFR 211 dictates the requirements for the laboratory controls, and many laboratories consistently received 483’s and Warning Letters indicating that implementation of these requirements is a critical issue with multiple QC laboratories. This session will review the key requirements for a pharmaceutical lab such as analytical validation and verification, GMP requirements for laboratory testing, the stability program. This webinar will also introduce the pitfalls of the lab operations and how to establish a workflow to keep the lab in the compliance state.

Learning Benefits:-

• GMP requirements of the pharmaceutical labs.
• Analytical Validation process and lifecycle management of analytical procedures.
• The use of USP monograph and procedure verification.
• The role of the stability program.
• Several pitfalls that typically found in QC labs.
• Key areas to focus on lab inspection.

Outline:-

• Introduction
• GMP requirements of the pharmaceutical labs
• Analytical Validation process and lifecycle management of the analytical procedure
• The role of the stability program
• Several pitfalls that typically found in a QC labs
• Key areas to focus on lab inspection

Who should attend:-

The following individuals or disciplines will benefit from attending this session:

• Quality Assurance personnel
• Quality Control personnel
• Research & Development
• Regulatory Affairs Professionals
• Validation
• Auditors