Sterile devices are free of viable microorganisms and the sterile barrier system is the key to maintaining this sterility until the medical device is ready to be used on a patient. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state, including maintaining this state for a defined period of time. These regulatory requirements relate to general safety and performance aspects of the products, and the requirements for independent, third-party conformity assessment of the processes for achieving and maintaining sterility. Evidence of an appropriate and stable sterile barrier system is important and expected when demonstrating conformity with the regulations.
These requirements are supported by a series of standards for maintaining sterility over time with appropriate sterile barrier systems.
This course provides an introduction to these regulatory requirements, as they relate to typical sterile barrier systems used for single-use and reusable medical devices, and how manufacturers may demonstrate compliance.
Benefits of Attending
- Gain an overview of the types of sterile barrier systems used for medical devices
- Understand the principles of sterile barrier system validation
- Learn the regulatory requirements for sterile barrier systems and how to comply
- Gain an awareness of the ISO 11607 series of standards
Please note that delegates will require access to a copy of ISO 11607-1 to gain the most from this training.
Certifications:
- CPD: 3 hours for your records
- Certificate of completion
Speakers
Annette Callaghan,
Sterile Management SystemsA 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).
Who Should Attend
- Quality Management System (QMS) specialists
- Quality, Packaging and Validation Engineers
- Regulatory Compliance specialists
- Internal Auditors
- Regulatory and Quality professionals
