Topics
- Examples for FDA 483 inspectional observations and warning letters
- FDA and International GLP regulations: 21 CFR Part 58, OECD
- Special organizational requirements
- Objectives and concepts of GLP`s
- SOP requirements: type, formats and enforcement
- Responsibilities: Management, Study director, QA, analysts
- Key requirements for equipment, facilities reference material, people
- GLP studies: preparation, conduct, documentation
- Records keeping: format, length of time, archiving and reprocessing
- Data generation and evaluation: raw data, intermediate results, final results
- Preparing for FDA inspections
- Strategies for Multi-site GLP Studies
Who should Attend
QA managers and personnel, Lab Supervisors and Managers, Analysts, GLP auditors, Consultants, IT managers and personnel and Teachers.
