Critical Factors for Sterile Product Manufacture

Key learning objectives are:-
- To review the key activities and processes which are critical to the success of sterile manufacturing operations
- To refresh delegates on the special nature of sterile products and understand the challenges involved in aseptic processing and the consequences of failure.
- To develop risk assessment methods and quantify risk
- To apply risk management techniques to control contamination in clean rooms
- Understand how the key aspects of the facility design, personnel, material flows, aseptic behaviours determine the success of aseptic processing.
- How to implement and perform a successful aseptic validation program including practical trail design
- To understand the current sterilisation & sanitisation processes and controls
- To understand the importance of critical utilities in sterile product manufacture including steam and high purity water.
- To understand the role of QC laboratories in sterile processes
- To understand the role of the QP in sterile manufacture
- To review the current regulatory requirements and trends in sterile manufacture
- To understand common GMP deficiencies and what inspectors are looking for.

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

This course covers all key aspects of sterile product manufacture, for both aseptically prepared and terminally sterilised products.