Course overview
Medical devices which will be aseptically manufactured, terminally sterilised or where their cleanliness is of importance in use need to be manufactured under controlled conditions. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state, including the environmental conditions under which manufacturing and primary packaging should take place. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving and maintaining sterility. Evidence of an appropriately controlled work environment is important and expected when demonstrating conformity with the regulations.
These requirements are supported by a series of standards on designing, operating, testing and classifying clean environments.
This course provides an introduction to these regulatory requirements as they relate to the design and management of a controlled working environment for the manufacture of medical devices and how manufacturers may demonstrate compliance.
CPD Hours: 6
Course Content
- Day 1
- Cleanroom design and operation
- Cleanroom classification and testing
- Microbiological monitoring
- Additional considerations
Speakers
Annette Callaghan
A quality management professional, chartered biologist and member of the Royal Society of Biology, with over 35 years’ experience in the medical device, pharmaceutical, biotechnology and food industries. Extensive knowledge of quality and environmental management systems, internal and third-party auditing and personnel training. Eligible to act as a Qualified Person as defined in Directive 2001/83/EC, as amended (previously 75/319 et al.) since 1993. A Qualified Notified Body Lead Auditor since 2002 (IRCA ref: 1182641).
