His subjects will include alignment between regulatory guidelines and ISO/CEN standards, the challenges of integrating holistic QRM with respect to the new Annex 1, and ARMM enabling next generation pharmaceutical cleanrooms to support Pharma 4.0, PAT and Real Time Release Testing (RTRT).
Conor firmly believes that Annex 1 will drive the increasing adoption of ARMM technologies, not only in CGT/ATMP, with short shelf-life products, but in wider Pharma and Biopharma applications due to uncertainties and limitations of delayed results, data integrity and the level of manual intervention in traditional sampling-based EM methods. The Annex 1 update introduces a formal requirement to apply QRM and develop a documented contamination control strategy, which is expected to encourage the scientific adoption of new monitoring technologies for predictive quality.
"Annex 1 will challenge us to better understand our manufacturing process and the impact of contamination sources. The BioTrak, with real-time viable airborne particle counting and as a validated Non-Inferior alternative method, is a game changer for root cause analysis and immediate intervention when a contamination event occurs."
Our customers and industry professionals in Ireland will know that Conor is Convenor of ISO/TC209 WG2 on Microbiological Contamination Control and Chair of the Irish Cleanroom Society. At the forthcoming NGPC conference, Conor will also co-chair a session on Annex 1.
Delegates attending the NGPC conference will be able to ask questions of Conor in person and seek advice on how best to implement Annex 1 and address all aspects of continuous Environmental Monitoring.
The conference takes place on 5th and 6th October at the Copthorne Tara Hotel, Scarsdale Place, Kensington, London. You can find more details about the conference online here.