Full Day Virtual Seminar : Annual GLP Refresher Course 2011

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