AMMI Global Expert Webinar: International Consensus Standards for Sterile Packaging Meeting Regulatory Requirements
Date: 12 October 2020 (Monday)
Non Members- RM100 per pax
The session will cover the essentials of sterile packaging validation, maintenance of sterility and other key features.
WHAT WILL YOU LEARN?
- The new EU Medical Device Regulation (MDR) – A summary of key aspects and the impact on Global Sterile Packaging Standards
ISO 11607- Packaging for sterile medical devices- latest revisions Feb 2019
- Deep dive on Usability:
– Aseptic presentation – risks and aspects to consider,
– Usability evaluation for aseptic presentation,
– New requirements for labelling of sterile packaging, new symbols
- ISO standard development
– The ISO process
– Development of ISO TS 16775 – the guidance for the application of ISO 11607-1/2
– Future amendment to ISO 11607 for risk management
WHO SHOULD ATTEND?
This training is recommended for those who are involved in Quality Control and Regulatory Affairs, Microbiologists, R&D and Manufacturing Operations, Packaging and Process Engineering, Procurement and Supply Chain Management, Quality Control and Regulatory Affairs, Marketing and Product Management as well as Sterilization Professionals
Thierry Wagner – Global Director of Regulatory and Standards
Products—Packaging” (ISO 11607), chairman of the Sterile Barrier Association (SBA), member of the Parenteral Drug Association (PDA) and actively involved in various ISO and CEN technical committees on medical and pharmaceutical packaging like CEN TC102 “Sterilizers for Medical Purposes—Packaging” (EN868) and ISO TC76 “Transfusion, infusion and injection equipment for medical and pharmaceutical use”.
Thierry has spent over 30 years working for DuPont in its polyester films and nonwovens businesses in a variety of assignments ranging from process development and project management to operations and business management. He is the convenor of ISO TC198/WG7 “Sterilization of Health Care
Thierry is also a member of ISO/TC 210 in charge of ISO 13485, medical device symbols, ASTM Committee F02 and of the CEN Advisory Board for Healthcare Standards-Europe (CEN ABHS). He earned a master’s degree in mechanical and process engineering from ETH Zürich in Switzerland. He is a featured speaker at international conferences and seminars on medical and pharmaceutical packaging regulatory aspects.