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As biotech and In Vitro Diagnostics (IVD) companies mature, the need for professionals with a broad understanding of the skills required to be effective in a biological product development environment will increase. In this course, learn the requirements for moving an IVD product from concept to regulatory approval and market launch. Topics include planning for success by setting product requirements & specifications to meet customer needs, critical path management, resource planning, principles of assay development, instrumentation, role and composition of the product development team, risk analysis, and IVD clinical and regulatory issues including compliance and complaint handling. Specific product development cases will be discussed.


Agenda:

Day 1

  • Introduction to IVDs
  • Drafting of a Package Insert
  • Product Development Process
  • Product/Customer Requirements
  • Design Control
  • Risk Analysis and Failure Mode and Effects Analysis

Day 2

  • Principles of assay development
  • Instrumentation and software for IVDs
  • Preclinical and Clinical Trial design
  • Companion Diagnostics
  • Case study in Cancer
  • IVD Regulatory Issues

Speakers:
  • Tammy Brach, MBA; Director Program Management, Dexcom
  • Larry Mimms, Ph.D., Chief Scientific Officer, Prometheus Labs
  • Al Maderazo, VP, Quality Assurance and Regulatory Affairs, GenMark Diagnostics
  • Damon Getman, Ph.D., Senior Principal Scientist and Director, Hologic
  • Valerie Day, MBA, Senior Director Program Management, Prometheus Labs

Note: Continental Breakfast and Lunch provided on both days of workshop.

Course Number: BIOL-40244
Credit: 2.00 unit(s)
Related Certificate Programs: Advanced Studies in Regulatory ScienceIn Vitro Diagnostics

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