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 Heather Harwood, Director, Art & Communications, at harwoodh@xavier.edu.
Supply Chains in China – Strategies for Regulatory Success
Presenter: Ames Gross
Predictive Capabilities Through a Living Metrics Model
Presenters: Tami Frederick; Agnes Ortega
Sweeping De-Regulation Through the 21st Century Cures Act?
Presenter: Jim O'Reilly
Building a Bridge Across Generations
Presenters: Linda Gravett; Jim Wulfeck; Grace Breen; Michael Kaminski; Ashley Goldberg; Catey Claridge
Update on Rx-360 Progress and Impact
Presenter: Ben Mills
Data Integrity: Detection and Successful Practices
Presenters: John Avellanet; Robert Tollefsen
Supply by Design: Good Supply Practices for the 21st Century
Presenters: Shawn Hopkins; Al Kentrup; Marla Phillips
ORA Key Initiatives
Presenter: Ellen Morrison
Top 3 Challenges for Successful Serialization Implementation Across Your Supply Chain
Presenters: Chris Howell; Matt Sample; Ken Stopar; Bill Webb
Your Company Bought a New Business. Now What?
Presenters: Charlene Banard; Ashley Goldberg; Stan Russell
Predictive Capabilities Through a Living Metrics Model
Presenters: Tami Frederick; Agnes Ortega
Maximizing Post-Merger Success
Presenter: Michael Taylor
FDA Metrics Program: Path Forward to Reduce Risks Within FDA and Across Industry
Presenter: Commander Tara Gooen Bizjak
FDA Investigator Case Study Insights
Presenters: Brent Conatser; Dell Moller; Robert Tollefsen
Predictive Capabilities Through a Living Metrics Model
Presenters: Tami Frederick; Agnes Ortega