PIC/s Annex 2a ATMP Revisions, Bio-Safety, Rapid Micro Method RMM and Contamination and Cross-Contamination Control Strategy
The 2021 ISPE Aseptic Conference 30th Anniversary will be held on 15 – 17 March offering attendees several unique perspectives and case studies across two separate tracks. For many years, the ISPE Aseptic Conference has been an integral part of my professional career and the most important kick-off event of the year where everyone who deals with aseptic production meets. In 2021, due to the ongoing COVID-19 pandemic, the 2020 ISPE Aseptic Conference will take place purely virtually, which does not prevent me from getting in touch with many participants through virtual networking, making new contacts and meeting friends, business partners, customers, colleagues and the ISPE family. As part of the 2021 ISPE Aseptic Conference Program Committee we have put together special highlights for the conference especially for this 2021 celebration. I’d like to introduce ATMPs, Bio-Safety and new approaches for Viable Monitoring as well as operator protection during manufacturing of highly potent products in my blog post.