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
Duration: 7 Hours
Group of 3 to 5 + 1 Thumb Drive/Recorded Version
Group of 6 to 10 + 1 Thumb Drive/Recorded Version
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
Speaker is currently the Group Leader for Analytics CMC Group and Senior Consultant with the Biologics Consulting Group specializing in Analytical, Stability, CMC, and GLP/GMP Quality Systems. She has assisted pharma and biotech organizations in the evaluation of analytical methods and method validation for a wide range of products from the pre-clinical phase to commercial phases. Some specific technical areas include small-molecule pharmaceuticals, well-characterized proteins including biosimilars and vaccines. Her consulting areas include GMP systems design and implementation focusing on laboratory and stability systems, data integrity, and equipment. She currently serves as an Editorial Advisor for Bioprocess International.