
Drug-Device Combination Products: Quality & Regulatory Requirements
19 – 21 September 2022, live online training
Request agenda
Summary
The challenges associated with drug-device combination products are complicated as they must be registered either as pharmaceutical or medical device products. This course will help you navigate this complicated regulatory landscape. You will return with an understanding of the medical device world as it applies to your drug/device combination, including risk management, clinical considerations, and design control.
Learning Objectives
- Understand the regulatory requirements for drug-device, device-drug combinations
- Generate critical quality attributes and critical process parameters to design capable processes
- Understand design control expectations
- Examine best practices for working with medical device suppliers and manufacturers
- Establish a control strategy to deliver safe and efficacious products
- Understand the difference between CQAs and process parameters
- Focus on the correct quality attributes
Key Topics
- Quality management systems
- Critical quality attributes
- Critical process parameters
- EU MDR
- Market access
- Post-market surveillance
- Key functional elements
- ISOs
Who should attend?
This course is suitable for all those involved in:
- Quality Control
- Product Technology Transfer
- Process Development
- Medical Device Engineering
- Production
- Regulatory Affairs
Past participants
- Executive Regulatory Affairs, Abbvie
- Global Head External Quality, Biogen
- QA Manager, F. Hoffmann-La Roche
- Senior Manager GLP/GMP, Merz Pharmaceuticals
- Senior Technical Regulatory Affairs Manager, Idorsia Pharmaceuticals
- Senior Technical Steward Devices, Novartis
- Manager, External Manufacturing Management, Ferring
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post-training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Revisit recorded sessions for 30 days
- Training in digital format
- Digital and LinkedIn certificates
Trainers

Drug-Device Combination Products: Quality & Regulatory Requirements
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
See the full training agenda