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

Date to be announced

Price available after dates are announced

TRAINING TIMES

TBDVienna
TBDLondon
TBDNew York
TBDLos Angeles

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

TRAINER

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.

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