This Radiation sterilization training will discuss how radiation sterilization works, the equipment involved, major issues with product sterilization via radiation, and the validation requirements. Routine process control and monitoring will be reviewed along with requirements to maintain the process effectiveness.
Why Should You Attend:
Radiation sterilization validation is a topic that results in many audit observations from the FDA and international regulatory bodies. Both Gamma and E-Beam radiation methods are validated following the same principles and standards. Proper understanding of the principles and requirements of the related standards is crucial to proper compliance and integrating them early in the product design can lead to quicker time to market.
This seminar will provide an overview of the requirements to validate medical devices for both Gamma and E-Beam sterilization. Validation is based on the international standard ISO 11137-1:2006 and ISO 11137-2:2006. In this one hour seminar you will obtain a basic understanding of the principles, core requirements of the ISO standard as well as related standards and guidance. We will define how radiation sterilization works, the equipment involved, major issues with product sterilization via radiation, and the validation requirements. Routine process control and monitoring will be reviewed along with requirements to maintain the process effectiveness.
This will be useful when reviewing validation plans, performing internal audits and dealing with regulators. It is also beneficial to R&D staff to understand the requirements so they may be incorporated into the design inputs correctly.
Areas Covered in the Seminar:
- Introduction.
- Terminology / Definitions.
- Radiation characterization / effectiveness.
- Process Equipment.
- Product and Material Issues.
- Process Definition.
- Validation IQ/OQ/PQ.
- Documentation, review and approval of validation.
- Routine Monitoring.
- Product Release.
- Maintenance of process effectiveness.
Who Will Benefit:
- RA Directors, managers and staff
- QA Directors, managers and staff
- Internal audit staff
- R&D Directors, managers and staff
Instructor Profile:
Mark Roberts, is the head of Roberts Consulting and Engineering (RCE), a consulting firm specializing in quality system and sterility assurance compliance. He was previously the Manager for the Western US for TÜV SÜD Product Service. He is an accredited lead auditor and notified body auditor. He still performs audits and product/sterilization file reviews for notified bodies on a contract basis.
He has 30 years of experience in the medical device industry. Prior to joining TÜV he was with Becton Dickinson in their corporate offices as manager of sterility assurance. He also held various positions in RA/QA, sterility and engineering for Baxter Healthcare. He is a member of AAMI and ASQC Biomedical. Publications include portions of the ASQC Biomedical Quality Auditor Handbook. He has also been an expert witness on quality systems and sterility for the FDA.
