Sterile devices are free of viable microorganisms and EO sterilization is one of the key processes in the production of sterile medical devices.
Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. 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 sterility. Evidence of successful sterilization by Ethylene Oxide is important and expected when demonstrating conformity with the regulations.
These requirements have been supported by a portfolio of standards on:
- Designating products as sterile;
- Validating and routinely controlling the sterilization process;
- Determining whether the sterilization process has any adverse effect on the devices; and
- Maintaining sterility over time with appropriate sterile barrier systems
This course provides an introduction to these regulatory requirements as they relate to EO sterilization and how manufacturers may demonstrate compliance.
Benefits in Attending
- Gain an overview of medical device sterilization by EO
- Understand the principles of EO validation for medical devices
- Learn the regulatory requirements for EO sterilization and how to comply
- Gain an awareness of supporting standards and their interrelationships
Please note that delegates will require access to a copy of ISO 11135 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
- Microbiologists and sterilization professionals
- Quality Management System (QMS) specialists
- Regulatory Compliance specialists
- Internal Auditors
- Regulatory and Quality professionals
