Good Laboratory Practice Regulations - Introduction and Strategies for Implementation

Complying with GLP regulations can increase the cost of a laboratory up to 30%. Companies or employees either don't know exactly what GLP really means, what procedures are required and how to implement GLP regulations. Lack of GLP knowledge is also an inspection issue as training plans should include basic GLP knowledge for everybody working in a GLP environment This seminar will give a good understanding of GLP regulations and recommendations and tools for implementation.

Areas Covered in the Session:

• FDA and International GLP regulations: 21 CFR Part 58, OECD
• Objectives and concepts of GLP's
• Special organizational requirements
• Responsibilities: Management, Study director, QA, analysts
• SOP requirements: type, formats and enforcement
• GLP studies: preparation, conduct, documentation
• Key requirements for equipment, facilities reference material, people
• Data generation and evaluation: raw data, intermediate results, final results
• Records keeping: format, length of time, archiving and reprocessing

• Good Laboratory Practices and Current Good Manufacturing Practices: 120 pages e-book
• Gap Analysis/Checklist: Good Laboratory Practice Regulations
• SOP: Archiving GLP Data and Other Documents

• Lab Supervisors and Managers
• QA managers and personnel
• GLP auditors
• GLP study directors
• Analysts
• Consultants
• Teachers