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