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

Course Description

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.
  • 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
  • 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

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

7 - 9 November 2023, Live Online Training
€1.850,00
James Pink

James Pink has over 20 years of experience in medical devices including 10 years as a lead auditor for European Notified Body. James is a contributor to several medical device standards committees including ISO13485, ISO 14971 and various product-related standards.

Training dates will be announced soon. In meantime, feel free to request an agenda.

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Course Description

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.
  • 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
  • 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

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

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.

Medical-Devices-Certificate-Course

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