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.

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