Process Validation for pharmaceutical and Biopharmaceuticals
February 26 - 27, 2013 - Toronto ON CA
IPA, AN AAPS COMPANY
Understanding the regulatory guidelines, implementation of lifecycle validation & industry best practices. Many industries are facing the challenge of bridging the gap between the former validation approach of “three batches and we’re done” to understanding how the new Process Validation stages work together to establish process predictability. As a result IPA, International Pharmaceutical academy is now offering a course on the New Process Validation guidance which is designed to facilitate the smooth transition from the former validation approach to include the new lifecycle approach which includes implementation of Process Validation (PV) and Continued Process Verification (CPV) from a practical perspective. The Lifecycle approach links product and process development to the commercial manufacturing process, and maintains the process in a state-of-control during routine production.