cGMP and Quality Issues for Biopharmaceuticals
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Who Should Attend
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Description
This course will quickly bring you up to speed on the most current FDA requirements for quality assurance and control of biopharmaceuticals. You will first be given the tools you need to keep up with the rapid pace of regulatory change and introduced to the “GAP analysis” method of assessing your current state of compliance. Next you will learn the level of compliance expected during early clinical development. Current compliance trends will be covered including detailed discussions of 21 CFR Part 11 compliance (electronic records and signatures), dealing effectively with OOS results and environmental monitoring. Proper techniques for internal and external auditing will be presented along with industry insider information on how to prepare your laboratory for FDA inspections.