Annex 1 - A Call to Action!

The new Annex 1 is finally out! - Impact on GMP Cleanrooms

Location
Pillo Hotel, Ashbourne, Co. Meath
Date
Tuesday, 31st January 2023
Registrations start at 9am
09:30 - 17:00
 

This is the second in our Annex 1 Roadshow series, coming to 7 industry locations around the country (Cork, Dublin, Limerick, Athlone, Galway, Sligo and Belfast), continuing our 'back to basics' theme, on the new Annex 1 guidance (a EMA & PIC/s joint effort. We will focus on QRM and a formal CCS (Contamination Control Strategy), setting requirements for cleanroom design, Classification vs Monitoring, and Total Particles & Viable EM. The first roadshow in Cork at the Radisson Blu hotel in Little Island, on the 12th December 2022 created great discussion among attendees. While there was not enough time during the afternoon workshop sessions to get into every nuance and subtle of some key clauses it is clear the Life Science industry has its work cut out to meet the deadline in August 2023.

This is a Free to Attend event with refreshments provided
but prior registration is required at: https://www.cleanrooms-ireland.ie/events/

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, the 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.

Please click on the link below to download the event flyer and detailed agenda:
ICS Annex 1 Roadshow Flyer 31st Jan 2023 (148 KB)
 

This event has been made possible thanks to the generous support of our Silver Corporate Sponsor*:

* We still have sponsorship opportunities 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.