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.Agenda: Eastern Standard Time10:00 AM to 12:00 Noon : Review of recent warning letters related to GLPs11 AM : 10 min - break with Q&A session12.00Noon to 1pm EST: Lunch1:00PM EST to 3.00PM EST: GLP requirements for Personnel Equipment and Facility2 PM EST: 10 min - break with Q&A session3:00pm EST to 3.15pm EST - Break3:15pm 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 documents4:15 PM EST : 10 min break with Q&A session5:15PM EST Final Q&A Session