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Understanding The revised versions of ISO 14644-1 & -2 Revision of EU GMP, volume 4, Annex 1

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.

 

Course overview

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.

 

Training sessions

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.

 

Workshop session:

  • Working through a practical classification test study.

  • Comparing with the old 1999 requirements.

 

Migrating to the new standard

  • Trialling.

  • Programme for changeover.

  • EU GMP regulatory position about the revised standards.

 

Discussion Q&A
 

 

Gordon Farquharson

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.

 

Date

April 11th 2016

 

Price

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

 

 

Registration

Send an e-mail to matts@biotekpro.se with participants and invoice details (incl. VAT.no.)

 

Questions?

Call us on +46 (0) 40 - 13 82 50

or send an e-mail to matts@biotekpro.se

 

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