Good Laboratory Practice Regulations - Introduction and Strategies for Implementation 2016

Topics

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

Who should Attend

Attendees from:

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