Ensuring you and your cleanroom facilities are up to date
Understanding and implementing the revised cleanroom standards
ISO 14644 part 1 and Part 2 (2015) |
ISO 14644-1 and -2 (2015) Training
BioTekPro proudly present this unique one-day training course with Mr Gordon
Farquharson. The training course helps you to understand and implement the newly
revised cleanroom standards ISO 14644 part 1 and part 2.
The two cleanrooms standards ISO 14644 part 1 and Part 2 has been undergoing
revision for nearly ten years. They are now finally approved and available for purchase,
use and implementation.
In order to facilitate this process Mr Gordon Farquharson, who was the convener of the
revision, comes to Malmö, Sweden, to present the various changes and assist in the
interpretation and use of the new documents.
Understand the new cleanroom standard requirements:
Revised requirements and method for classifying and monitoring cleanrooms and clean air devices.
Understanding the changes 1999 to 2015, and why the improvements were made.
What is the impact on GMPs for medicines and medical devices?
What is the impact on real-time monitoring and periodic testing of cleanrooms?
The requirements in other industries.
Working through a practical classification test study.
Comparing with the old 1999 requirements.
Migrating to the new standard
Programme for changeover.
EU GMP regulatory position about the revised standards.
Gordon Farquharson, B.Sc.(Hons), C.Eng. is a Chartered Consulting Engineer with more than 30 years experience of quality & safety critical processes and facilities used by industries such as Healthcare, Life Science, Micro-electronics, etc. He is Principal of Critical Systems Ltd, a global consultancy company. He is also an executive consultant for PharmOut Pty Ltd, a consulting business based in Australia, working in the ASEAN region.
April 11th 2016
SEK 10 750:- excl. VAT
The fee includes course material, certificate, lunch and refreshments
Early bird Discount
Registration prior March 11th 2016: SEK 1 000:- / participant
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