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33842 Conferences

Full Day Virtual Seminar : Annual GLP Refresher Course

Added by Referral on 2011-01-04

Conference Dates:

Start Date Start Date: 2011-08-12
Last Date Last Day: 2011-08-12

Conference Contact Info:

Contact Person Contact Person: Referral
Email Email: referral@complianceonline.com
Address Address: 2600 E. Bayshore Road, Online Event,Palo Alto, CA, 94303, United States
Phone Tel: 650-620-3915
Phone Fax: 650-963-2556

Conference Description:

Why Should You Attend:
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.

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
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