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Module 7 – Good Aseptic Practices & Sterile Products (24 – 26 September 2018) – 3 day Course
From Monday 24 September 2018 -  08:00am
To Wednesday 26 September 2018 - 05:00pm
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Aim: This subject is designed to facilitate the development of knowledge and practical skills in the assessment of special risksassociated with the manufacture of sterile pharmaceuticals and to develop and evaluate strategies and plans that will ensure acceptable sterility assurance levels.

Day 1       AM Assess the regulatory requirements for aseptic manufacturing processes in order to provide recommendations for their application to

ensure compliance

PM Evaluate the processing and compliance risks associated with aseptic processing and terminal sterilization

Day 2       AM Critically evaluate strategies for bioburden control

PM Evaluate the available processes for sterilisation and depyrogenation

Day 3        AM Prepare risk based environmental assessments PM Understand the updates to ISO14644-1 and -2:2015

 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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