For your convenience the presentations that will be made at PharmaLink are loaded onto this page as we receive them from the presenters, unless a presenter has requested 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 Mason Rick, Program Manager, at 513-745-3016 or
PharmaLink 2016 Supporting Documents
1. Xavier Comments on FDA “Request for Quality Metrics” Draft Guidance for Industry (FDA-2015-D-2537)
2. MHRA Pre-Inspection Compliance Report Document
PharmaLink 2015 Deliverables
1. Xavier Proposal for New Inspection Paradigm
2. PharmaLink 2015 Data Integrity Checklist
Below are the PharmaLink 2015 Presentations
(To view past PharmaLink Presentations visit our archives page.)
Speakers Session Title Presentation
Ellen Morrison Update from ORA
Steve Wolfgang and Robert Iser FDA-Driven Initiatives through FDASIA Implementation
Marla Phillips and Dale Carter Establishing Good Supply Practices (GSPs)
Sharon Johnson and Chris Claeboe Barriers to Quality and Supply Chain Excellence
Martin Kuhn and Cindy Kuhlman-Voss Toyota Production System – Cultural Requirements
Michael Taylor, Bob Zinser, and Jim Wulfeck Nobel Prize-based Alignment Optimization
Richard Andrews MHRA Perspective on Global Supply Chain Challenges
Paul Weninger and Sean Deng Global Supply Chain Risk Management Case Studies
Gwyn Murdoch, Zach Johnson, and Tom Marsden Systematic Approach to Managing Your Global Supply Chain
Michael Davidson, Steven Mendivil, Laura Cannon, and Dee Carri How to Measure Quality Performance
Cheryl Flurer FDA Forensic Chemistry Center
Domenic Veneziano, Anna Brannen, Jim O'Reilly, and Tim Darst Held at the Border? Understand Why.
Kathleen Culver, Dell Moller, and Chris Middendorf FDA Investigator Insights