The presentation provides practical insights into the implementation of quality guidelines at Pfizer, by highlighting the implications of ICH Q12 especially for the manufacturing process. Departing from general regulatory considerations on Product Lifecycle Management, the talk will address various issues related to PQS, GMP compliance and management of manufacturing changes and outline the main improvements that result from this. Finally, by sharing practical experiences of how to apply the new guidelines, the talk will include some thoughts on the regulatory dimension of further advancements on the way to smart manufacturing.

In this session, you will learn more about

• The connection of regulatory considerations and technology
• The relevance of ICH Q12 for the manufacturing process
• The main improvements with regard both to quality as well as to efficiency
• The potentials of flexible and harmonized regulatory approaches for future Smart Manufacturing