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. Note: Presentations are listed in alphabetical order by title.


Add Value Through Advanced Supply Chain Strategies You Can Implement Today!

Presenters:

  • David Lowndes, Senior Vice President, Head of Small Molecule Operating Unit, Technical Operations, Takeda

  • Eda Ross Montgomery, Ph.D., Head PRO.GO: Process Governance and Data Management, Takeda


Applying Emerging Technology to Advance Your Operations

Presenters:

  • CDR Tara Gooen Bizjak, Senior Science Policy Advisor, Office of Policy for Pharmaceutical Quality, FDA

  • Mark Christy, Fabric Home & Power Quality Assurance, Procter & Gamble

  • Tom Garcia, Research Fellow in Global CMC, Pfizer

  • Stu Merdian, Corporate QA, Audits and Assessments and Digitization Leader, Procter & Gamble


Are Your Drugs Counterfeit? How FDA Can Help You!    

Presenter:

  • Cheryl Flurer, Supervisory Chemist, FDA


Chief Quality Officers - Redesigning the Field of Quality for the 21st Century

Presenters:

  • Bob Miller, Senior Vice President, Quality, Gilead

  • Tony Mire-Sluis, Head of Global Quality, AstraZeneca

  • Pam Schofield, Vice President, Global Quality Assurance, Procter & Gamble

  • Peter Shearstone, Vice President, Global Quality Assurance and Regulatory Affairs, Thermo Fisher Scientific

  • Jacques Zimmowitch, Global Head of Quality, Elanco


External Surveillance Programs to Protect and Promote Patient Health

Presenters:

  • Steve McCarthy, Vice President of Digital Innovation, Sparta Systems (former Vice President, J&J)

  • Brian McCormick, Associate Director, Global Patient Safety, Perrigo


Fact or Fiction? Filing Challenges for Emerging Technology

Presenters:

  • CDR Tara Gooen Bizjak, Senior Science Policy Advisor, Office of Policy for Pharmaceutical Quality, FDA

  • Leslie Weiss, Director, Global CMC Regulatory Affairs at Janssen Research & Development, LLC; a division of Johnson and Johnson


FDA Mock Inspection: Knock Knock! Guess Who’s at Your Door?

Presenters:

  • Steve Eastham, Supervisor, Consumer Safety Officer, FDA

  • Dell Moller, Supervisory Investigator, FDA

  • Nicholas L. Paulin, Drug Specialist and Pre-Approval Manager, FDA, Cincinnati District Office

  • Lindsey Schwierjohann, Consumer Safety Officer, Drug Specialist

  • LCDR Jeffrey Meng, Director of Investigations Branch, Division of Pharmaceutical Quality Operations III, ORA, FDA


FDA Provides Insight on the World of FDA Investigators!

Presenter:

  • Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, Office of Regulatory Affairs, FDA


FDA Quality Metrics Program: FDA Gemba Journey with Industry through Feedback and Site Visit Options

Presenter:

  • Jennifer Maguire, Division Director (Acting), OPQ/OS/Division of Quality Intelligence, Risk Analysis and Modelling, FDA-CDER


How Qualified Are You to be Part of Your Own Supply Chain?

Presenters:

  • Adam Hostetler, Director of Operations, Cook MyoSite

  • Hal Hunt, Director of Technical Operations and CMC Supply Chain, Trevena


Industry 4.0 and the Total Cost of Quality:  The Bi-Modal Challenge Facing our Industry Today

Presenter:

  • Steve McCarthy, Vice President of Digital Innovation, Sparta Systems


Is There Power and Potential for Blockchain in the Pharmaceutical Industry?

Presenters:

  • Eric Garvin (Co-Lead of the MediLedger Project), Pharma Solutions Executive, Chronicled

  • Matt Sample, VP, Manufacturer Operations, AmerisourceBergen


Quality Risk Management Across the Product Lifecycle: An Enterprise-Wide Approach

Presenters:

  • Stephanie Gaulding, Principal Consultant, DPS Group

  • Brandon Persinger, Associate Director of Corporate Quality Compliance, Perrigo

  • Michael Reske, Quality Engineering Manager, Perrigo


Real Life Application of ICH Q12 in Action

Presenters: 

  • Megan McMahon, Director, Global Regulatory CMC, Pfizer

  • Mahesh Ramanadham, OPF Senior Scientific and Policy Advisor (Acting), FDA-CDER


Situational Analysis for You to “Navigate the Gray” with Practical Solutions for Real-World Quality Challenges

Speakers:  

  • Raul Cardona, Ph.D., Group VP, Global Quality, Pharmaceutical Services, Thermo Fisher Scientific

  • Jason Mieding, Senior Director, Supply Chain North America, Thermo Fisher Scientific

  • Neil Stinson, Associate Director, Pharmaceutical Technology & Technical Services, Purdue Pharma


Top 10 FDA 483 Inspectional Observations: How and Why

Presenters: 

  • Art Czabaniuk, Program Division Director, Division of Pharmaceutical Quality Operations III, ORA, FDA (invited)

  • Dell Moller, Supervisory Investigator, FDA


You Don’t Get a Second Chance to Make a First Impression with FDA! 

Presenters:

  • Art Czabaniuk, Program Division Director, Division of Pharmaceutical Quality Operations III, FDA-ORA (invited)

  • Dell Moller, Supervisory Investigator, FDA

  • Steve Niedelman, Lead Quality System & Compliance Consultant, King & Spalding

  • Nicholas L. Paulin, Drug Specialist and Pre-Approval Manager, FDA, Cincinnati District Office (invited)

  • John Taylor, President and Principal, Compliance and Regulatory Affairs, Greenleaf Health


Your Market Strategy for China Could be at Risk!

Presenters:

  • David Lowndes, Senior Vice President, Head of Small Molecule Operating Unit, Technical Operations, Takeda

  • Steve Rota, Sr. Supply Director, AstraZeneca