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This course provides an extensive introduction to the regulatory requirements governing pharmaceutical clean room operation, and details the aseptic filling and terminal sterilisation methods for producing sterile products. The delegates will gain an appreciation of the significance of sterile products to the patient, and understand why there is intensive regulatory interest worldwide in the control of sterile product manufacture.
Suitability
This course will provide valuable underpinning knowledge to all personnel working for companies responsible for the manufacture of sterile products. It will be of benefit to those working in sterile products manufacturing, QC (especially environmental monitoring personnel), QA personnel as well as support engineers.
At the end of the course you will:
Understand the risks associated with sterile products
Appreciate the requirements for contamination control and how this links to clean room design
Understand the methods for terminal sterilisation and processes involved in aseptic product manufacture
Appreciate the importance of people and the need for trained personnel
