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. Archived Presentations:  The PharmaLink 2016 presentations and supporting documents are provided below.  To access past PharmaLink Presentations, visit our archives page. PharmaLink 2016 Supporting Documents
1. Xavier University - PwC Pharmaceutical Metrics White Paper (January 2016)
2. Xavier Comments on FDA “Request for Quality Metrics” Draft Guidance for Industry (FDA-2015-D-2537)
3. MHRA Pre-Inspection Compliance Report Document
 
PharmaLink 2015 Deliverables
1. Xavier Proposal for New Inspection Paradigm
2. PharmaLink 2015 Data Integrity Checklist   2017 PharmaLink Presentations will be posted soon.
Speakers Session Title Presentation
Ilisa Bernstein Office of Compliance Key Initiatives
Kathleen Culver, Tracy Moore, and Paul Vogel Protecting and Promoting Data Integrity
Tracey Moore MHRA Update - Strategic Priorities and Initiatives
Paul Weninger Operating in India and Southeast Asia
Connie Jung Serialization - Are you ready?
David Lowndes, Dale Carter, and Jim Wulfeck Paradigm Shift - Meaningful Solutions for your Supply Chain
Lawrence Yu The Strategic Direction and 2016 Goals of the Office of Pharmaceutical Quality
Ellen Morrison Office of Regulatory Affairs Update and New Strategic District Operations
Michael Taylor and Marla Phillips How to Measure Quality Culture and Why
David Lowndes and Joseph Northington Pharmaceutical Metrics. Value Proposition?
John Taylor The 21st Century Cures Act - Goals and Impact
Tim Watson ICH Q12 - Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
Andy Polywacz and Harry Gill Quality and Supply Chain Excellence: Overcoming Complex Barriers
Steve Niedelman, Brent Conatser, Kathleen Culver, and Steve Eastham Proactive and Systematic Quality Implementation - Case Studies across functional areas
Kathleen Culver and Tracy Moore FDA and MHRA Investigator Insights