Good Laboratory Practices - A Comprehensive Overview

Why Should You Attend:

Annual training on Good Laboratory Practices is a requirement for all staff working in GLP laboratories. Inadequate training can be expensive in the long run due to the need for repeated studies for regulatory filing.

This 3-hr session will provide the attendee with a review of recent warning letters related to the GLPs and a discussion on the focus areas for FDA inspectors. The discussion will be followed by a review of each of the key GLP systems with an emphasis on the Analytical Laboratory Systems. Common pitfalls in the implementation of the GLPs will be addressed during the discussion related to each area.

Areas Covered in the Seminar:

• Review of recent 483s related to the GLPs.
• GLP requirements for Personnel Equipment and Facility.
• Steps in a GLP study.
• Test Article.
• GLP Study Protocols.
• Documentation.
• Study report.
• Archival of Study related documents.