Process Scale-up, Validation and Technology Transfer for Medical Devices

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 7 days
• Training in digital format
• Digital and LinkedIn certificates

Process Scale-up, Validation and Technology Transfer for Medical Devices

Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.