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

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

Date to be announced

Contact us for more info
Price available after dates are announced

TRAINING TIMES

  • TBDVienna
  • TBDLondon
  • TBDNew York
  • TBDLos Angeles
Online Training



LEARNING OBJECTIVES

Learning Objective

Navigate the complex medical device regulatory landscape

Navigate the complex medical device regulatory landscape

Learning Objective

Understand how to manage process and design changes

Understand how to manage process and design changes

Learning Objective

Learn how to use statistical methods

Learn how to use statistical methods

Learning Objective

Gain new perspectives on how to design in quality (QbD principles)

Gain new perspectives on how to design in quality (QbD principles)

Learning Objective

Build transparent and methodical processes to achieve commercial-scale production

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

TRAINER

James Pink

James Pink

Health Sciences and Medical Devices Consultant

James Pink has over 25 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 a product 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.

Learn More →