Full Day Virtual Seminar : Annual GLP Refresher Webinar

Why Should You Attend:
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.

We saw a significant increase in the number of warning letters in 2009 and 2010 and 2011 is expected to bring in an even larger set of changes as FDA continues to cope with the huge increase in the number of overseas drug manufacturers. This comprehensive 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. Common pitfalls in the implementation of the GLPs will be addressed during the discussion related to each area.

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 PM : Review of recent warning letters related to GLPs.
• 12:00 PM to 01:00 PM : Lunch
• 01:00 PM to 03:00 PM : GLP requirements for Personnel Equipment and Facility.
• 03:00 PM to 03:15 PM : Break
• 03:15 PM to 05:15 PM : Steps in a GLP study. GLP requirement for the Test Article, GLP Study Protocols, Documentation, Study report and Archival of Study related documents.
• 05:15 PM : 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

Instructor Profile:
Nanda Subbarao, Dr. Subbarao received her Ph.D. in Bio-organic Chemistry from the Indian Institute of Technology, Bombay, India. Her hands-on industrial experience covers stability and laboratory cGMP systems for both biologics and conventional drugs. She has extensive experience in evaluation of analytical methods and method validation for products ranging from conventional drugs, well characterized proteins, vaccines, cell therapy and gene therapy products, ranging from pre-clinical phase to commercial phases.

She is an ASQ Certified Quality Auditor with expertise in setup of cGMP/GLP complaint Quality Systems for laboratory and stability programs as well as upgrade of existing Quality Systems for products during development and in commercial phase.

She is currently a Senior Consultant with the Biologics Consulting Group specializing in Analytical, Stability, CMC and GLP/GMP Quality Systems. She serves on the AAPS Stability Focus Group Steering Committee. She also serves on the AAPS National Biotechnology Conference Programming Committee for 2009 to 2011 as the Regulatory Sciences lead.

Follow us :