Gordon Farquharson

 

Gordon Farquharson

Principal of Critical Systems Ltd

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, LifeScience, Micro-electronics, etc.

Gordon is Principal of Critical Systems Ltd, a global consultancy
company. Gordon is also an executive consultant for
PharmOut Pty Ltd, a consulting business based in Australia,
working in the ASEAN region.

    

 

Presentation Nr 2

Annex 1 - “Step change or minor adjustments in sterile products GMP requirements”

  • Publication, comment, and implementation intentions
  • Cleanroom contamination control changes
  • New WFI guidance
  • Environmental monitoring evolution
  • Revised process requirements – PUPSIT
  • Summary – the big changes

 

Presentation Nr 7

Understanding ventilation effectiveness in non-Unidirectional flow cleanrooms

  • Understanding the GMP compliance requirements, and Good Engineering Practice aspects
  • Understanding the air-change requirements in the GMPs including recovery time
  • Explore the importance of understanding ventilation effectiveness – Concepts of ACE (air change effectiveness) and CRE (contamination reduction effectiveness)
  • How these concepts are embodied in ISO 14644-4 (in revision), and ISO 14644-16 (new Energy Code of Practice)
  • Using these concepts for new designs and cleanroom energy efficiency upgrade projects

 

 

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