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Critical Factors for Sterile Product Manufacturing

: 26 Nov 2019 - 29 Nov 2019

: Barnard Castle, United Kingdom

Sector: Pharmaceutical

Type: Training

New course topics include: RABS & Isolator Technology, Sterilisation Methods, Aseptic Processing & Process Simulation, HVAC, HACCP Principles, Cold Chain Transport, Risk Management Workshops.


Open discussion sessions on current best practices and regulatory trends in sterile product manufacture will be coupled with case studies to illustrate key points.


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 bio burden 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


Honeyman Training Facilities
Barnard Castle
County Durham
DL12 8BN
United Kingdom


Honeyman Group Ltd
Phone: +44 (0) 1833 690101
Email: enquiries@honeyman.co.uk
Visit: https://www.honeymangroup.com/

<< Previous article
Good Manufacturing P...
Next article > >
Manufacturing Steril...