Summary
The course has been developed to introduce you to the international requirements for design control and risk management of combination products. There is a particular emphasis on drug – device combinations and drug delivery devices that are regulated as combination products or drug-device combinations in Europe requiring the notified body opinion (NBOp).
We assume no prior knowledge of design control or risk management as many of the attendees will be more familiar with pharmaceutical regulation and cGMP.
Our course is based upon worked examples facilitated by the tutor but also enables participants to discuss their products (without breaching intellectual property restrictions!).
The sessions are a blend of regulatory requirements discussing in particular ISO13485:2016 section 7.1 and 7.3 in particular but also CFR21 Part 4 and CFR21 Part 820.30.
Learning Objectives
- Critically evaluate product design to ensure compliance with essential safety and performance requirements
- Understand the regulatory requirements for drug-device, device-drug combinations
- Understand design control expectations
- Identify requirements of key International Standards and regulatory requirements relative to risk management and design control
- Understand the importance of human factors and useability engineering
- Identify how risk management affects quality management system practices
Key Topics
- Risk management and design control fundamentals
- Standards and regulations
- Usability engineering
- Design Controls Requirements
- Design Changes
- Post-approval
- Risk Analysis, Evaluation And Controls
Who should attend?
This course is suitable for all those involved in:
- Regulatory Affairs
- Quality Control/ Assurance/ Engineering
- Product Development/ Engineering/ Technology Transfer
- Process Development
- Research & Development
Past participants
- Senior Process Expert, B. Braun
- Head of Primary Packaging & Process Development, Boehringer Ingelheim
- Tech Transfer Operations Lead, Novartis
- Process Development Manager, Stevanato Group
- Product Transfer, Biokit
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 7 days
- Training in digital format
- Digital and LinkedIn certificates
Trainers
Design Control and Risk Management For Combination Products
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
