Annex 1 – A Call to Action!
The new Annex 1 is finally out! - Impact on GMP Cleanrooms
Radisson Blu Hotel, Little Island, Co Cork
Monday 12th December 2022
08:00 – 17:00
This is the first of an Annex 1 Roadshow, coming to up to 7 industry locations around the country, continuing our ‘back to basics’ theme, target sight set on the new Annex 1 guidance (a EMA & PIC/s joint effort), QRM and a formal CCS (Contamination Control Strategy), setting requirements for cleanroom design and classification, and Viable & Non-Viable EM.
Morning: Annex 1 Introduction & Panel Discussion
A series of short bullet point presentations will target key elements and clauses of the new Annex 1 including QRM and CCS, relationship to Pharma 4.0, links to ISO 14644 standards, context with other Annexes (Annex 11 - Data Integrity & Annex 15 - Q&V), as well as other GMP guidance (ATMPs & short shelf-life products).
Afternoon: Workshops on Key Clauses
This will be a series of round table sessions where attendees can discuss and debate specific issues and challenges around key clauses in the new Annex 1 (now 59 pages vs 16), before sharing outcomes and conclusions with everyone. Clauses to be covered include how to deal with the 5 Micron particle size at Cleanroom Classification, and link to Environmental Monitoring, Qualification during Simulated Operations, Air velocity at Working Position, Airflow Viz, role of PALs, MALs & PTHs for segregation, Isolator applications and challenges in continuous EM, including adoption of ARMM.
This is a Free to Attend event supported by our sponsors* and with refreshments provided,
but prior registration is required at:
* We still have sponsorship opportunities for this event or for all our Annex 1 Forum Roadshows in 2022/2023, with different options to choose from. To discuss further, please contact Chris Delaney, ICS Convenor for Training & Events on 086 889 0907.