+1-610-668-CORE (2673) info@corehf.com

Presented by: Michael Gross, Ph.D., RAC of Chimera Consulting North America LLC in collaboration with Adam R. Shames, MBA of Core Human Factors, Inc.

May 27-28, 2015
Chemical Heritage Foundation
Conference Center
315 Chestnut Street
Philadelphia, PA 19106

Through interactive classroom lectures, discussion of case studies and sharing of experience, this advanced training, covering medical devices and device-containing combination products, is intended to enhance participant understanding of:

  • Optimizing your company’s human factors design process through optimized design validation practices that can be applied to every development project in order to reduce development delays and improve the chances of first-time approval.
  • How to utilize human factors studies, to identify design flaws, potential use errors and their mitigations, during development of a new device or device constituent part of a combination product, or when modifying an existing device constituent part to be used in a combination product.
  • Why it’s never too late to consider applying human factors engineering principles. How to validate the design of a legacy product
  • Understanding differences between CDRH, CDER, and CBER human factors expectations.
  • How to establish reasonable human factors/design validation expectations with FDA reviewers so that FDA review meetings have successful outcomes.
  • The most common reasons why companies and FDA differ over product design validation issues.
  • How to write and submit a human factors design validation protocol to FDA.
  • How to have a successful outcome for a human factors design validation study on the first attempt.
  • Pitfalls: Case study review and discussion of various human factors deficiencies cited by FDA.

WHO SHOULD ATTEND:
This training program is intended for individuals working in product development, engineering, manufacturing, quality assurance and regulatory affairs roles in the pharmaceutical and medical device industries. Participants will gain a comprehensive understanding of FDA’s regulation of the development and manufacture of combination products and how to interpret guidance, conform to standards, comply with regulatory requirements and improve their ability to manage complex product development and regulatory compliance problems.

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