Summary
This interactive 3-day training will provide you with practical tools and knowledge for process risk assessment during scale-up and technology transfer of medical devices. You will receive an in-depth update on the regulatory landscape, presented interactively through case studies involving a cannula, femoral prosthesis, and an infusion pump.
Learning Objectives
- Navigate the complex medical device regulatory landscape
- Understand how to manage process and design changes
- Learn how to use statistical methods
- Gain new perspectives on how to design in quality (QbD principles)
- Build transparent and methodical processes to achieve commercial-scale production
Key Topics
- FDA & EU regulatory requirements
- Using standards
- Statistical methods
- Risk Management Process
- Quality by design Principles
- Managing suppliers
- Design planning/validation/transfer/scale-up
- Process planning/validation/transfer/scale-up
Who should attend?
This course is designed for those involved with quality assurance, regulatory, engineering, manufacturing in medical device design, development and manufacturing.
- Quality Managers & Engineers
- Medical Device Engineers
- Manufacturing Engineers
- Process Engineers
- Validation Managers, Engineers and Technicians
- R&D and Product Development Managers, Engineers and Scientists
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 30 days
- Training in digital format
- Digital and LinkedIn certificates
Trainers
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