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Date: 9th March, 2010

Location: On-Line, North America

Summary:
Pharmaceutical - Web Seminar

Click here to Register for this Seminar

2 - Session Live Web Training
Session 1: Tuesday, March 9, 2010
Session 2: Thursday, March 18, 2010

The objective of this extensive training is to explore GMP updates and FDA regulatory expectations, as well as assist in assuring that your organization is maintaining itself within a cGMP compliance framework.

Discussion Points:
Latest initiatives taken by the Margaret Hamburg, M.D., FDA Commissioner Updates to the FDA 21 CFR Parts 210/211 The Six Systems involved in FDA abbreviated and full audits Process Analytical Technology (PAT) The management of electronic data based on 21 CFR Part 11 Reviewing how GMP compliance can make your organization more efficient Understanding current FDA expectations through review of current Warning Letters Using Warning Letter information to improve your facilities performance and conformance to cGMPs 'Pitfalls' encountered with Warning Letter responses.

GMP Annual Training –Exploring Good Manufacturing Practices Updates and FDA Regulatory Expectations - 2- Session Webinar