Scale-up and Technology Transfer for Medical Devices

Summary

By means of case studies and lessons learned, this 3-day online training will provide delegates with the practical knowledge needed for successful process scale-up, verification and technology transfer of medical devices

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
• Manufacturing Engineers
• Validation Managers, Engineers and Technicians
• R&D and Product Development Managers, Engineers and Scientists

Learning Objectives

• Manage Risks Through GMP
• Overcome Regulatory Hurdles and Avoid Showstoppers
• Ensure Consistent Product Performance
• Build Transparent and Methodical Processes to Achieve Commercial-Scale Production
• Avoid Supply Chain Bottleneck
• Real Industry Case Studies and Lessons Learned

Key Topics

• Good Manufacturing Practice
• Regulatory Planning
• Process Transfer Design
• Product Design & Risk Management
• Scale-up Planning
• Managing Changes
• Process Qualification & Verification

Programme

• 3 days of interactive learning
• Exchange experience with colleagues
• Training materials in digital format
• All delegates will receive digital & LinkedIn certificates