The mapping of a successful sterilization validation program for medical devices can be challenging. From assessing the impact of your manufacturing environment, to your packaging design and choice of sterilization methods, many factors will impact how you validate your sterilization process. While parts of the program are simple, others are very complex, and it can be difficult to know where to begin and what is required.
During this Webinar, you will learn about the many factors to consider when developing and registering a sterile product to ensure your product sterilization process is properly validated and documented, including:
- Applicable FDA and international regulations/guidance
- Terminal sterilization vs. Aseptic processing
- The right sterilization method for the right materials
- The impact of your manufacturing environment and processes
- Packaging considerations
- Sterilization validation and ongoing maintenance sterility testing
- Preparing for an audit
- Current FDA views on sterilization and the impact to your 510K
Who should attend?
Managers, directors, engineers and scientists responsible for research and development, product development, quality assurance and regulatory compliance.