Event Detail
GMP Annual Training –Exploring Good Manufacturing Practices Updates and FDA Regulatory Expectations
March 9 - 18, 2010
- Live Webinar CANADA
BenAstrum
2-Session Live Web Training: Session 1: Tuesday, March 9, 2010 Session 2: Thursday, March 18, 2010 (9:20 a.m. - 11:30 a.m. EST) (8:20 a.m. - 10:30 a.m. CST) (6:20 a.m. - 8:30 a.m. PST) Speaker: Barry A. Friedman, PhD 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