Manufacturing Sterile Products
Training
In Reading
Description
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Type
Training
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Level
Intermediate
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Location
Reading
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Duration
1 Day
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.
Facilities
Location
Start date
Start date
Reviews
Subjects
- Regulatory Compliance
- Good Manufacturing Practice (GMP)
- Sterile Products Manufacture
- Pharmaceutical Clean Room Operation
- Aseptic filling and terminal sterilisation methods
- Pharmaceutical Industry
- Quality Testing
- Clean room design
- Contamination risks
- Quality Training
Teachers and trainers (1)
Andy Martin
Tutor
Course programme
Course Overview
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.
Learning Outcomes
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
Additional information
Manufacturing Sterile Products