Full Day Virtual Seminar : Annual GLP Refresher Course 2011
11 Feb 2011
Webinar
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
Past Events
Full Day Virtual Seminar : Annual GLP Refresher Course 2011 - 11 Feb 2011, Webinar (12732)
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Important
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