It is our pleasure to announce the Verification, Validation, and Uncertainty Quantification (VVUQ) Workshop organized by the SB3C Industry Committee.  This workshop aims to educate participants on how VVUQ can be properly handled in a biomedical industry setting, with particular emphasis on the ASME V&V-40 standard and FDA regulatory pathways.  The workshop will include a combination of lectures, case studies, and hands-on discussions.

Participants who complete the entire workshop in-person will receive an attendance certificate from the ASME V&V 40–Verification and Validation in Computational Modeling of Medical Devices sub-committee and 3.5 CEUs credits.  This highly industry-relevant workshop also aims to create an environment at SB3C that facilitates industry-academia connection and collaboration.  The workshop will be in-person on Wednesday, June 22, 9:30AM~1:30PM.  A virtual option will also be available with no attendance certificate nor CEU offered.

Participant Target Outcomes:

  • An understanding of the regulatory framework for using Computer Modeling & Simulations (CM&S) in submissions
  • How to establish the credibility requirements of a computational model
  • How to format CM&S results for regulatory submissions

Upon completion attendees are expected to become familiar with the development process of Standard Operating Procedure for VVUQ in an industry setting.

Schedule

9:30am Introduction and FDA Regulatory Submission
10:30am ASME VV-40 Standards
11:30am Example Case studies
12:30pm Interactive practice and discussions

Light refreshments will be offered between the last two sessions (by courtesy of Ansys).

Workshop Registration Process

Conference registration is required to attend this workshop.  There is no additional registration cost for the workshop. Registration will be closed when workshop capacity is filled.

 To register for the workshop:

  • First register for the main SB3C conference by following instructions for main conference registration.
  • Get your registration ID from your main conference registration confirmation email.
  • Register for the VVUQ workshop by clicking on the VVUQ Workshop registration link.
  • Please note that the closest airport to the conference site is Salisbury-Wicomico (40 mi)

Organizers

Marc Horner, ANSYS
Robert Allen, Albert Einstein College of Medicine
Anil Attaluri, Penn State University
Ravi Kodwani, Altair
Lin Li, Eli Lilly
Ethan Kung, Clemson University