Data Integrity in Pharmaceutical Manufacturing, March 23, 2023 – Recording available
In this free webinar, Ulrich Koellisch gives an overview on the current best practices for data integrity with a special focus on pharmaceutical manufacturing operations.
The talk covers the key points of data integrity in ISPE and PDA guidelines combined with personal experience of finding and implementing DI solutions ‘in the field’ followed by a ‘look into the future’ with very recent inspection findings from FDA’s Warning Letters and 483s. How will manufacturing operations change to enable more data-driven decision making? How is this reflected in current regulatory guidelines published by EMA, FDA and ICH?
At the end of the webinar, we will have an FAQ and Q&A session.