Design Controls for Drug-Device Combination Products
Online
The “Design Controls for Drug-Device Combination Products” live online training gives a comprehensive overview of the technical and regulatory requirements for the development and life-cycle management of drug-device combination products with a focus on both EU and US requirements. It covers the basics of design controls, distinctions between drugs, devices and combination products, and how to comply with applicable regulations and standards, as well as key elements of Risk Management and Usability Engineering, illustrated with practical case studies. The course explains how to plan and conduct design activities (planning, input/output, verification/validation, design transfer and change control) within a GMP context and discusses FDA and EU expectations including quality systems and documentation. It is aimed at professionals across development, quality, regulatory affairs and project management involved in combination product projects.
Planned lectures
- Design Controls – An Introduction
- Design Planning and Design Review
- EU Requirements for Drug-Device Combinations
- Design Input
- Design Output
- Design Verification
- Design Transfer
- Design Changes