This webinar is designed to provide guidance on the regulatory test process in relation to sterile barrier packaging and their associated medical devices. Content will be applicable to both new and legacy devices requiring resubmission due to a significant change, for example, transfer between sterilization modalities.
The overview will provide valuable in-site into post-sterilization qualification testing, touching on:
• ISO11607-1 sterile packaging requirements
• Distribution simulation
• Shelf-life stability/aging
• Sterile barrier testing
• Device performance testing
Mr. Philip Roxby (B.Eng.) is the Technical Services Manager for STERIS Galway, Ireland. Starting as a Mechanical Engineer, Philip has held various technical positions in the organisation over the last 16 years. His current role involves management of the cross-discipline Technical Services team responsible for medical device and sterile packaging verification & validation testing, test method validation, new-test introduction, and process improvement. Other industries served include pharma, automotive and electronics.
This webinar is complimentary for all the staff of the AMMI members, on a first-come-first-served basis. Kindly use your work email to register.
This webinar is also open to the public. Registration is RM420 per pax inclusive of SST.
Certificate of Participation will be issued.