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This interactive course will include discussions of current regulatory expectations including Data Integrity and is 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.
This webinar will begin with a review of recent warning letters related to the GLPs and a discussion of the focus areas of the inspectors. The discussion will be followed by a review of each of the key GLP systems with an emphasis on the Analytical Laboratory Systems and Data Integrity. Common pitfalls in the implementation of the GLPs will be addressed during the discussion related to each area.
• All personnel involved in GLP studies
• Lab personnel
• Study Directors
• QA personnel
• QA Management
• Documentation personnel
• R&D Lab personnel
• R&D Lab Supervisors
· Review of recent warning letters related to the GLPs
· Discussion of the focus areas of the Inspectors.
· The GLP Org chart
· Roles and responsibilities of the Management, Study Director, QAU and Archivist
· Personnel training
· Requirements for the animal housing areas
· Requirements for storing the test article and reference
· Requirements for the lab space
· Requirement for Archival space
· Equipment design
· Maintenance, Calibration and Qualification of Equipment
· Testing and Certificate of Analysis
· Labeling the test article and Reference
· Storage of the Test Article and Reference
· The Study Protocol
· Documentation during the study – Good Documentation Practices
· The Study report
· Documents that need to be archived
· Specimens that need to be archived
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
12.00 Noon to 1 pm 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
3.00 pm EST to 3.15 pm EST: Break
3.15 pm EST to 5.15 pm 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
5.15 PM EST: Final Q&A Session