Past PharmaLink Presentations

For your convenience the presentations, deliverables, and other materials from past PharmaLink conferences have been loaded onto this page.
Speakers Session Title Presentation
Ellen Morrison PharmaLink 2015: Update from ORA
Steve Wolfgang and Robert Iser PharmaLink 2015: FDA-Driven Initiatives through FDASIA Implementation
Marla Phillips and Dale Carter PharmaLink 2015: Establishing Good Supply Practices (GSPs)
Sharon Johnson and Chris Claeboe PharmaLink 2015: Barriers to Quality and Supply Chain Excellence
Martin Kuhn and Cindy Kuhlman-Voss PharmaLink 2015: Toyota Production System – Cultural Requirements
Michael Taylor, Bob Zinser, and Jim Wulfeck PharmaLink 2015: Nobel Prize-based Alignment Optimization
Richard Andrews PharmaLink 2015: MHRA Perspective on Global Supply Chain Challenges
Paul Weninger and Sean Deng PharmaLink 2015: Global Supply Chain Risk Management Case Studies
Gwyn Murdoch, Zach Johnson, and Tom Marsden PharmaLink 2015: Systematic Approach to Managing Your Global Supply Chain
Michael Davidson, Steven Mendivil, Laura Cannon, and Dee Carri PharmaLink 2015: How to Measure Quality Performance
Cheryl Flurer PharmaLink 2015: FDA Forensic Chemistry Center
Domenic Veneziano, Anna Brannen, Jim O'Reilly, and Tim Darst PharmaLink 2015: Held at the Border? Understand Why.
Kathleen Culver, Dell Moller, and Chris Middendorf PharmaLink 2015: FDA Investigator Insights
Marla Phillips PharmaLink 2014: Xavier Proposal for CDER Metrics Program Deliverable
Marla Phillips PharmaLink 2014: Leading and Lagging Indicators Deliverable
Marla Phillips PharmaLink 2014: Xavier Health - Integrity of Supply Initiative Deliverable
Russell Wesdyk PharmaLink 2014: Next Steps for the CDER Challenge
Fran Gregory PharmaLink 2014: Business Drivers and Incentivizing Quality
Snehal Srikrishna, Daisy Guha Niyogi, Jack Solomon PharmaLink 2014: Comparing Metrics with Other Companies – Is There a Way? Why is it Vital?
Dinesh Kumar, Emily Leongini, Carolyn Becker, Steve Niedelman PharmaLink 2014: FDASIA: The New Frontier
Jaspreet Gill, Bill Webb PharmaLink 2014: Innovation Versus Safety – CDER’s Restructure
Michael Davidson, Matt Anderson PharmaLink 2014: Complex Supply Chain Development
Dale Carter, Marla A. Phillips PharmaLink 2014: Increasing Supply Chain Reliability – Shifting Paradigms
Mark Birse PharmaLink 2014: MHRA Perspective on Global Supply Chain Challenges
Rick Seibert, Terri Hernan, Rick Saffee, Kathleen Culver, Mark Birse, James Mullen, Laura Parks, David Lowndes PharmaLink 2014: Operationalizing Effective Integrated Supply Chains
Fionnuala Walsh, Dale Huff, Barry Blake, Hedley Rees, Michael Davidson PharmaLink 2014: How Did They Do That? Learn from Other Industries!
Fionnuala Walsh, James Mullen, Jack Kraeutler, Jim Wulfeck PharmaLink 2014: How to Influence Meaningful Change
Kathleen Culver, Mark Birse, Rebeca Rodriguez, Dale Carter, Steve Jenison, Bill Webb PharmaLink 2014: Supplier Partnership Systems that Work
Kathleen Culver, Mark Birse, Dell Moller, Rebeca Rodriguez, Steve Eastham, David Miser PharmaLink 2014: FDA and MHRA Investigator Insights
Petra Doerr PharmaLink 2013: Driving Safety and Innovation
Steve Solomon, Murdoch, O'Reilly, Niedelman, Long PharmaLink 2013: FDASIA
Hussain Mooraj and Roddy Martin PharmaLink 2013: Collaboration Beyond Borders – The Future of Life Sciences
Michael Barnes PharmaLink 2013: Drug Shortages
Al Kentrup PharmaLink 2013: How Do We Gain Greater Supply Chain Reliability
David Churchward PharmaLink 2013: Drug Shortages: The Regulatory Viewpoint
David Churchward PharmaLink 2013: Regulatory Science Innovation
Barbara Nollau PharmaLink 2013: Supplier Management Models that Work
Jim Wulfeck PharmaLink 2013: A.C.T. Checkup
Pekka Kurki PharmaLink 2013: Regulatory Science and Regulation
David Churchward PharmaLink 2013: MHRA Inspection Trends and Regulatory Actions
Kathleen Culver PharmaLink 2013: FDA Inspection Trends
Laura Parks PharmaLink 2013: Outsourcing Business Impact
Michael Davidson PharmaLink 2013: Quality Culture
Gawayne Mahboubian-Jones GOC 2012: Supply Chain Development
Leroy Schwarz, Hui Shao, and Tan Miller GOC 2012: Finished Product Distribution
Laura Birou GOC 2012: Total Cost of Quality
Dirk Rodgers GOC 2012: How Drug Pedigrees Protect The Supply Chain
Michael Eakins GOC 2012: USP Chapter Development Impact--GDPs
Kathleen Culver GOC 2012: FDA Inspectional Approach
Mee-Shew Cheung and Philippe Andre GOC 2012: How to Operate in Different Regions
Denyse Julien GOC 2012: Supplier Selection
Jonathan Patroni GOC 2012: Establishing a Meaningful Supplier Qualification / Partnership Program
Jeff Orlov GOC 2012: Self Inspections
Jack Solomon and Christopher Smith GOC 2012: Quality Agreements
David Stokes GOC 2012: ERP
Deb Autor GOC 2011: Pathway to Global Product Safety and Quality
Richard Andrews and Jair Calixto GOC 2011: Global Regulatory Expectations
Javaid Cheema GOC 2011: Price versus Total Cost of Ownsership
Andrew Cox and David Schoneker GOC 2011: Strategic Procurement
James Ryan GOC 2011: Development and Commercial Contracts
Alan Minsk Functional Quality Agreements
Andrew McNicoll GOC 2011: Meaningful Metrics
Kathleen Culver and Richard Andrews GOC 2011: FDA Inspection Trends and Enforcement
Jim O'Reilly GOC 2011: McNeil Case Study
Steve Niedelman GOC 2011: Living Under Consent Decree
Jack Solomon GOC 2011: Practical Risk Management
Steve Niedelman and Raphael Brykman GOC 2011: Supplier Qualification
Irwin Silverstein GOC 2011: 3rd Party Initiatives
Eric Ahuja, Stephen Closs, John LePore, and Chris Watts GOC 2011: Quality by Design
Robert Coleman, Vicky Stoakes, and Christopher Smith GOC 2011: Audit Panel Discussion
Hedley Rees, Pat Crowley, and Ed Kobeliski GOC 2011: The Power of Integrated Supply Chains
John Curran GOC 2011: End-to-End Planning
Brian Johnson GOC 2011: Global Complex Supply Chains