Full Description

PDA's newest technical report Process Validation: A Lifecycle Approach presents timely and real world guidance for the application of a lifecycle approach to process validation. The lifecycle approach has been the focus of recent process validation guidance from major regulatory agencies and represents a significant change in expectations in this area. This new technical report, part of the PCMO(sm) initiative, will review requirements for process validation studies across the three-stage approach defined by FDA and also discuss best practices for integration with supporting Quality Systems.

Product Details

Published: 02/01/2013 ISBN(s): 9780939459513 Number of Pages: 102 File Size: 1 file , 1.3 MB Product Code(s): 01060