Scale-up and Technology Transfer for Medical Devices

Place
Online training
Site visit
Dates
Next Dates
In-house Available
10 - 12 March 2021
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

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.

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
Request Full Agenda

Trainers

James Pink

James Pink has over 20 years of experience in the medical devices industry including 10 years as a healthcare technology expert and lead auditor for a leading European notified body. He began his career as aproduct designer in the oil tools industry moving into medical physics and clinical engineering at the Royal Hallamshire Hospital in Sheffield, UK. His industry experience includes managing product development and quality assuranceprograms for active and non-active implantable and combination products. James is a contributor to several medical device standards committees including ISO13485, ISO 14971 and various product-related standards.

James Pink

James Pink has over 20 years of experience in the medical devices industry including 10 years as a healthcare technology expert and lead auditor for a leading European notified body. He began his career as aproduct designer in the oil tools industry moving into medical physics and clinical engineering at the Royal Hallamshire Hospital in Sheffield, UK. His industry experience includes managing product development and quality assuranceprograms for active and non-active implantable and combination products. James is a contributor to several medical device standards committees including ISO13485, ISO 14971 and various product-related standards.

Tour info

Price per Delegate (EUR)

Online Training

1250.00

Public Training

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Testimonials

Request Full Agenda

For the detailed agenda with a full breakdown of the individual sessions fill out this form.

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Contact us

Lydia Makori

l.makori@symmetric.events
+421 222 200 543