2017 Presentations

For your convenience, the FDA/Xavier PharmaLink 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. The PharmaLink 2017 presentations and supporting documents are provided below.     PharmaLink 2017 Supporting Documents:   Past PharmaLink Conference Deliverables:
2017 PharmaLink Presentations are posted as they are received.
Speakers Session Title Presentation
Ames Gross Supply Chains in China – Strategies for Regulatory Success
Tami Frederick and Agnes Ortega Predictive Capabilities through a Living Metrics Model.
Jim O'Reilly Sweeping De-Regulation through the 21st Century Cures Act?
Linda Gravett, Jim Wulfeck, Grace Breen, Michael Kaminski, Ashley Goldberg, Catey Claridge Building a Bridge Across Generations
Ben Mills Update on Rx-360 Progress and Impact
John Avellanet and Robert Tollefsen Data Integrity - Detection and Successful Practices
Shawn Hopkins Al Kentrup, Marla Phillips Supply by Design - Good Supply Practices for the 21st Century
Ellen Morrison ORA Key Initiatives
Chris Howell, Matt Sample, Ken Stopar, & Bill Webb Top 3 Challenges for Successful Serialization Implementation across your Supply Chain
Charlene Banard, Ashley Goldberg, & Stan Russell Your Company Bought a new Business - Now What?
Tami Frederick & Agnes Ortega Predictive Capabilities through a Living Metrics Model
Michael Taylor Maximizing Post-Merger Success
Commander Tara Gooen Bizjak FDA Metrics Program - Path Forward to Reduce Risks within FDA and across Industry
Brent Conatser, Dell Moller, Robert Tollefsen FDA Investigator Case Study Insights
Tami Frederick & Agnes Ortega Predictive Capabilities through a Living Metrics Model