This highly interactive course will include detailed discussions of current regulatory expectations and is therefore suitable for individuals new to the pharmaceutical industry and also serves as a refresher course for others. It also has an emphasis on recent inspection trends and will therefore be of interest to the experienced pharmaceutical laboratory professional.
Duration:6 hours of instruction, one hour lunch, 15 min breaks as they fit into the schedule.
Agenda: Eastern Standard Time - 10:00 AM to 12:00 Noon : Review of recent warning letters related to GLPs
- 11 AM : 10 min - break with Q&A session
- 12.00Noon to 1pm EST: Lunch
- 1:00PM EST to 3.00PM EST: GLP requirements for Personnel Equipment and Facility
- 2 PM EST: 10 min - break with Q&A session
- 3:00pm EST to 3.15pm EST - Break
- 3:15pm EST to 5.15pm EST - Steps in a GLP study. GLP requirement for the Test Article, GLP Study Protocols, Documentation, Study report and Archival of Study related documents
- 4:15 PM EST : 10 min break with Q&A session
- 5:15PM EST Final Q&A Session
Course Syllabus: - Recent warning letters
- Review of recent warning letters related to the GLPs
- Discussion of the focus areas of the Inspectors
- GLP requirements for Personnel
- The GLP Org chart
- Roles and responsibilities of the Management, Study Director, QAU and Archivist
- Personnel training
- GLP requirements for the Facility
- Requirements for the animal housing areas
- Requirements for storing the test article and reference
- Requirements for the lab space
- Requirement for Archival space
- GLP requirements for the Equipment
- Equipment design
- Maintenance, Calibration and Qualification of Equipment
- GLP Test Article and Reference
- Testing and Certificate of Analysis
- Labeling the test article and Reference
- Storage of the Test Article and Reference
- Documentation of the GLP Study
- The Study Protocol
- Documentation during the study – Good Documentation Practices
- The Study report
- GLP Study Records
- Documents that need to be archived
- Specimens that need to be archived
Who Will Benefit: - All personnel involved in GLP studies
- Lab personnel
- Study Directors
- QA personnel
- QA Management
- Documentation personnel
- R&D Lab personnel
- R&D Lab Supervisors
