For your convenience, the Xavier Combination Products Summit presentations are loaded onto this page as they are received from the presenters, unless a presenter has requested that their presentation not be posted. In keeping with Xavier’s conservation commitment, printed versions of presentations will not be available at the conference. If you have any questions, please contact Stacie Ball, Program Manager, at 513-745-3483 or balls2@xavier.edu.


2017 CPS Presentations

 

Global Regulatory Strategies for Combination Product Registration and Change Management

Presenters

  • Rick Chapman
  • Jason Lipman

Drug vs. Device vs. Combination Product Development: A Foundation

Presenter

  • Susan Neadle

Practical Stability and Shelf-Life Successful Practices and Considerations

Presenters

  • Ashley Boam
  • Steve Holcroft
  • John McMichael
  • Alberto Velez

Risk Management and Formative Human Factor studies (ISO 14971)

Presenters:  

  • Valerie Fenster
  • Sara Waxberg McNew

Verification, Validation and Summative Human Factor Testing

Presenter

  • Scott Thiel

21 CFR Part 4 Inspection Readiness

Presenters

  • Sandra Boyd
  • Melissa Burns
  • James Dunnie

Post-Market Reporting Challenges and Successful Practices for Combination Products

Presenter

  • Khaudeja Bano, Abbott Diagnostics

Case Studies: Global Regulatory Strategies for Combination Product Registration and Change Management

Presenters:

  • Ashley Boam
  • Rick Chapman
  • Jason Lipman
  • John McMichael
  • Kirsten Paulson
  • Suzette Roan
  • John “Barr” Weiner