Join our next free webinar on: Revised Annex 1 2022. The impact on Cleanroom technology in the Pharma & Life Sciences - on 26th October - 10.15am for a 10.30 am BST start
The webinar will be delivered by: Gordon Farquharson, B.Sc.; C.Eng. Chair BSI LBI/030 committee; President The Contamination Control Network (CCN)
Industry has been waiting for this for more than 5 years. The first draft for public scrutiny was savaged by more than 6000 substantive comments, leading eventually to a final document published by the European Commission on the 22nd August 2022. An identical PIC/S version has also been published. A majority of the changes have a 12 month implementation period.
Join this informative webinar to learn about the essential changes and additions from the 2008 version, and use these to plan how you’re going to assess the impact and implement the changed and new requirements.
Benefits of attendance:
- Obtain an early heads-up of the important changes that affect cleanrooms and associated controlled environments from an authoritative source.
- Understand the underlying principles behind some of the changes.
- Recognise some of the requirements that are still unclear and confusing, requiring industry response.
- Your attendance qualifies for the opportunity of CCN membership.
- The scope for the webinar will include the following:
- Understanding the concept of the Contamination Control Strategy (CCS)
- The links to ICH Q9, Quality Risk Management (QRM)
- Expectations of use of Cleanrooms vs Isolators vs RABS
- More requirements for Air locks and gowning rooms…..still some confusing text
- New requirements for pressurisation & airflow visualisation
- More detail about cleanroom & clean air device qualification and links to Annex 15
- Understanding the new revised table on air cleanliness for particle counter classification
- Unidirectional airflow velocities….still very confusing language
- Some small changes to environmental and process monitoring requirements
- And finally, a suggested approach to assessment and managing the changes.
Who should attend this webinar on Revised Annex 1 2022?
This webinar is targeted at all professionals and technicians involved with environmental contamination control:
QA/QC team members
Cleanroom, clean air device, & barrier technology designers, suppliers & contractors
Testing and certification personnel
Attendees qualify for membership of the CCN on application, renewable annually.
Please send an email to [email protected] with your full name, company name and email address. and you will be sent the registration link.
We look forward to seeing you on the webinar.