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Critical Factors for Sterile Product Manufacturing

: 26 Nov 2019 - 29 Nov 2019

: Barnard Castle, United Kingdom

Sector: Pharmaceutical

Type: Training

Course Content:

  • Review of international regulatory guidelines related to sterile product manufacture
  • Review of current deficiencies in sterile product manufacture
  • Basic microbiology and sources of contamination
  • Review of critical control points for bioburden control in a typical aseptic process
  • Sterilisation steps including terminal sterilisation
  • Sterilisation processes for irradiation of components
  • Classification and functionality of clean rooms and cleanroom design principles
  • Challenges in aseptic manufacture
  • Risk management of contamination in cleanrooms
  • Risk assessment method, quantification of risk and management
  • Garment gowning procedures and garment management
  • Cleanroom behaviour, personnel movements, disinfection procedures
  • Regulatory expectations for aseptic validation
  • Designing, performing media fills and interpreting results
  • Key aspects of quality critical utilities, including design, testing, and operation
  • Filtration types and theory, filter selection and integrity testing
  • Auditing pharmaceutical QC laboratories
  • Understanding the role and responsibilities of the QP
  • Effective CAPA systems in sterile product manufacture
  • Sterile product inspection techniques including manual, automated and regulatory trends

Whether involved in Production, QA, QC, Engineering or Regulatory Affairs, this course will be relevant to you.

Find out more / register here:


Barnard Castle
United Kingdom


Honeyman Group Ltd

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