Join this webinar to learn more on some of the challenges that are coming your way with the change to a European Medical Device Regulation (MDR) and an updated USP 661.1. Learn why the choice of the right partner is as important as the choice of the right material and what is the importance of change control when it comes to the resins you select for your Healthcare applications.
An increasingly important trend in the Healthcare industry in recent years has been the more and more stringent regulatory demands on the entire value chain with the end goal to ensure patient safety. High level of quality, protection and health for the end users as well as supporting innovation and making sure that the new innovative medical and diagnostic devices or pharmaceutical packaging reach patients in a timely manner have been at the heart of recently announced changes in the Medical Device Directive (MDD) in Europe and in the US Pharmacopeia (USP).
This webinar scrutinizes the implications of modernizing the Medical Device Directive and turning it into a Medical Device Regulation from a raw material point of view. How this may affect your medical devices or in vitro diagnostics and what is to be considered for the choice of the right material and the selection of reliable partner are also covered.
Another key aspect in the changing regulatory requirements that is tackled is the update of the US Pharmacopeia. The focus is on USP Chapter 661.1 Plastic Materials of Construction and what the foreseen modifications may mean for the Healthcare players in the US market.
Additionally, be it a medical/diagnostic device or pharmaceutical packaging, producers need the assurance that the materials they qualify for use today can also be used for years to follow. This means, for instance, receiving a recipe/formulation lock-down commitment, extended notification of change period, appropriate pharmacopeia testing results and FDA DMF (Drug Master File) registration.
We will have a live Q&A at the end of the presentation.
Paulo Cavacas,
Healthcare Business Development Manager, Borealis
Paulo Cavacas is Business Development Manager for Healthcare at Borealis. He has over 20 years' broad experience in the polymer industry, spanning from technical responsibilities as product developer, application development and technical service, to marketing responsibilities in the last 10 years within the PE film area. Since January 2018, Paulo heads the Healthcare marketing team at Borealis.
Anja Gottschalk,
Healthcare Application Development Engineer, Borealis
Anja Gottschalk joined Borealis in June 2016 as Application Development Engineer Healthcare, responsible for the European and Asian market. She already has more than 20 years of experience in the plastics area in application development, technical service and material management in Automotive, Packaging and Healthcare based on her degree in plastics engineering. She is based in her home office near Frankfurt, Germany.
- Learn some of the challenges ahead of the Healthcare industry due to the changing regulatory requirements
- Experience why change control is as important as any compendial testing
- Packaging Engineer
- Material Scientist
- Product Development
- Research & Development Engineer
- Compliance/Regulation Manager
- Product Stewardship Specialist
- Raw Material Purchasing Manager
- Head of Packaging
- Head of R&D
