Best Practices in 21 CFR Part 11-Advanced Level, Philadelphia, PA, USA
Event Sep 29
This course provides you with advanced level training for complying with 21 CFR Part 11. In line with the FDAs new risk-based GMPs initiative and recent guidance on the scope and applicability of Part 11, we focus on applying risk analysis and management techniques, including Fault Tree Analysis, Failure Mode Effects Analysis and Hazard and Critical Control Points, to Part 11 compliance efforts. Identify current regulatory requirements in Part 11 and the predicate rules.