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The Irish Cleanroom Society and its sponsors are delighted to announce the first of its online cleanroom regional forums*.
A special thanks to our sponsors as without them these free to attend events would not be possible.
Date: Monday, 26th April 2021
Time: 2pm to 5pm
The focus in our first forum will be on GMP Cleanroom EM and the link to the latest Annex 1 with guidance on applying QRM and Contamination Control Strategy. This forum, Part 1 of 2, will concentrate specifically on integrated EM.
Astech is launching a new division in Ireland with Lighthouse Worldwide Solutions and will look at the differences between Classification and Monitoring. They are NOT the same but people are still confused about the essential differences. The correct application of ISO 14644-1:2015 for Classification and ISO 14644-2:2015 for Monitoring will be discussed.
We will also talk about integrated EM as part of Annex 1 new CCS in both APC for Non Viable EM and airborne sampling as part of Viable EM.
To provide a balance in Part 1, we have invited Charles River Laboratories to do a "Deep Dive" into a particularly tricky type of Viable EM -being Fungal ID at this forum- and how the recently published EN 17141:2020 on Microbiological Control can be applied.
The intention during Part 2 will be to include a focus on Rapid Microbiological Methods (RMM) and Alternative Microbiological Methods (AMM) and how the new EN 17141:2020 can assist in EM.
Programme & Topics - Integrated EM in a GMP Cleanroom (Part 1)
- 14:00: Opening & Introduction to your Speakers and Topics
- 14:15: Astech - Ronan Banerjee and Hasim Solmaz
Applying new Annex 1 Concepts of CCS based on QRM in GMP Cleanrooms - Classification vs Monitoring
- 14:30: Astech - Ronan Banerjee and Jason Kelly
Applying new Annex 1 concepts of CCS based on QRM in GMP Cleanrooms – Non Viable APC and Viable Sampling Techniques
- 15:00: Interactive Example | Case Study | Panel Discussion
- 15:15: Break
- 15:30: Charles River Laboratories - Duncan Barlow
Fungal ID - Case Study in applying EN17141 in Viable EM
- 16:15: Interactive Example | Case Study | Panel Discussion
- 16:30: Roundtable Panel to Close - How EM Comes Together
ICS Forums are free to attend but spaces are limited so please register as soon as possible on https://www.cleanrooms-ireland.ie/events/ or email at email@example.com.
Feel free to forward the forum invitation below to anyone who might be interested in attending:
Invitation ICS Cleanroom Forum.26.04.2021 (243.6 KB)
*Please note that our ICS online cleanroom regional forums will be held via Zoom. The sessions and chat messages will be recorded. While Zoom's chat is end-to-end encrypted; the audio and video features are not. The Irish Cleanroom Society reserves the right to use screenshots, audio and video recordings of our cleanroom seminars/forums for communication purposes in print, online and/or other media. Also, chats will be stored by the ICS to record relevant questions and answers during our panel discussions. By joining our Zoom Regional Forum, you agree to this policy.
For further information, please contact Chris Delaney, ICS Education & Training Convenor | M: +353 (0)86 8890907 - E: firstname.lastname@example.org.