James L Drinkwater

 

 

James L Drinkwater

Head of Aseptic processing technologies & GMP compliance F Ziel GmbH

Chairman and Joint leader of PHSS Bio-contamination special interest group

PHSS - Pharmaceutical and Healthcare Sciences
Societyrincipal of Critical Systems Ltd

 

 

 

 

Föreläsning 1 (av 2)

OBS! Första föreläsningen är inställd
och ersatt av Föreläsning 2, se nedan

Quality Risk Management and requirements in revised Annex 1

  • Quality risk management (QRM) principles and Annex 1 revision – what are the principles and how are they applied?
  • Adaption of generic GMP guidance applied to a new process and how QRM applies in practice.
  • Connection of QRM and CCS; Contamination control strategy – an upcoming revised Annex 1 requirement.

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Föreläsning 2 (av 2)

 

Quality Risk Management (QRM) in Annex 1 considering a Contamination Control Strategy (CCS) with interactions between microbiological control
via disinfection and sterilization: Case study Vial filling line

  • Key points about VHP/vH202 science and process when considering application in barrier technology for bio-decontamination
  • Discussion about Fragility of VHP and MHRA Blog.
  • PHSS clarity on GMP guidance: Assurance of Sterility of surfaces that contact product contact parts e.g. Filling stopper bowls.

 

 

 

 

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