+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.

June 14-16, 2016 (3 days) 

Barbizon Palace, Amsterdam

Through interactive classroom lectures, discussion of case studies and sharing of experience, this 3-day advanced training is intended to enhance participant understanding of the topics listed below.

Human Factors:

  • Building and then optimizing your company’s human factors and usability engineering process and how that can be applied to every development project in order to reduce development delays and improve the chances of first-time success.
  • Understanding the different human factors and usability expectations of the three US FDA centers (CDRH, CDER, and CBER) and EU Notified Bodies.
  • Establishing reasonable expectations with reviewers so that review meetings and submissions have successful outcomes.
  • Utilizing human factors and usability studies to identify potential use errors and their mitigations during development of a new device or when modifying an existing device.
  • Writing a Summative Evaluation protocol for human factors and usability engineering and when it’s necessary to submit it for review prior to execution.
  • The most significant human factors and usability deficiencies cited by the US FDA and EU Notified Bodies over the past decade.
  • The most common reasons why companies, regulators and Notified Bodies differ over human factors and usability issues.
  • Applying human factors and usability engineering principles to legacy products.
  • Integrating human factors and usability engineering into your process for evaluating potential device suppliers.
  • Asking your device supplier the key human factors and usability questions that will determine whether you should proceed with sourcing from them.

Combination Product Good Manufacturing Practice Regulations:

  • How to comply with current quality systems regulations, directives, guidance and standards for device-containing combination/borderline products and their applicability to pharmaceutical and medical device developers, contract manufacturers and constituent part and component part manufacturers.
  • Interpretation of current quality system draft guidance, guidance, industry best compliance practices, recent inspectional experience and FDA enforcement action for medical devices and device containing combination products.
  • How to implement and utilize design controls, including design verification and validation testing, during development of medical devices and device containing combination products.
  • What to do about a Design History File for a legacy product.
  • Including compliance information in marketing applications.
  • Combination Product Breaking News and Hot Topics.

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 the regulation of development and manufacture of drug delivery devices and 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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