APEC Supply Chain Security Toolkit


  • Katie Neckers, Regulatory Counsel, Office of Compliance, FDA

  • Phillip P. Nguyen M.D., DABFM, Director, International Regulatory Affairs and Programs, United States Pharmacopeia (USP)

Beyond Metrics Through the Power of Artificial Intelligence: Applications You Can Use in Quality Today


  • Xavier AI Initiative - CPQA Team: Charlene Banard, Senior Vice President, Global Quality, Technical Operations, Shire Pharmaceuticals

  • Xavier AI Initiative - CLS Team: Berkman Sahiner, Electrical Engineer, FDA-CDRH; Kumar Madurai, Principal Consultant, CTG

Big Data Analytics:  Right-Sizing Operational Excellence


  • Michael Shepherd, AI Research Technologist, Dell EMC

  • Ryan Smith, VP of Product & Engineering, Sight Machine

Day 2 Opening


  • Cathleen Carson, Associate Director, Treyburn & Supplier Quality Assurance, Purdue Pharma

FDA Investigator Case Study Insights


  • Brent Conatser, Senior Consultant, Elanco Animal Health

  • Art O. Czabaniuk, Program Division Director, Division of Pharmaceutical Quality Operations III, ORA, FDA

  • Dell Moller, Supervisory Investigator, FDA

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

FDA Office of Regulatory Affairs Update and Strategic Priorities  


  • Ellen Morrison, Assistant Commissioner for for Medical Products and Tobacco Operations, FDA-ORA

Global Trade Compliance and Successful Practices


  • Andrea Jeglum, Director, Global Trade and Controlled Substance Compliance, Brand Protection, Shire

  • John Morelli, Associate Director of Transportation, Shire

  • Sean Murray, Partner, Miller & Company (Trade Compliance Counsel)

  • Karen Stone, License Broker, Anchor Customs Brokerage

How Do Global Regulators Decide Who to Inspect?


  • Elizabeth Philpy, Senior Advisor, Office of Surveillance, Office of Pharmaceutical Quality, CDER

  • Tracy Moore, Senior GMDP Inspector and GMDP Operations Manager, MHRA

The ICH Q12 Solution


  • Ajay Pazhayattil, Industrial Pharmacist

New Legislation and the Impact to Your Product Approvals


  • Christina Markus, Partner, King & Spalding

Regulatory Strategy for Supply Chain Success


  • Diana L. Grohs, Senior Manager, External Party Quality Operations, Pharmaceutical Sciences Small Molecules, Pfizer

  • Scott R. Mackin, Senior Manager, Clinical Drug Product Supply and Sourcing, Pfizer

Strategic Supply Chain Development through the Last Mile


  • Terrence Jones, Director-IT Relationship Management, AmerisourceBergen Specialty Group

  • Michelle Rich, Associate Director of Program Development, Xavier Health, Xavier University

  • Matt Sample, Senior Director, Secure Supply Chain, AmerisourceBergen

  • David Ulrich, QA Director - Supply Chain, Abbvie

Supply by Design – Meaningful Supplier Engagement


  • Troy Fugate (GSP Initiative Co-Leader), Compliance Insight

  • Dale Carter, Head of Quality, Business Line Silica, Region North America, Evonik

Supply by Design: New! “Relationship Risk”


  • Elaine Shannon, Senior Director - Global Quality Compliance and Systems Knowledge Management, Takeda

  • Patrick Henry, Strategic Account Manager, Avantor Puritan Products

Total Quality Ownership Enterprise-wide: The Missing Piece of the Puzzle


  • Patrick Hughes, Quality Engineering Manager, Energy Products, Ethicon

TPLC Playbook: Putting the Lifecycle Matrix in Action


  • Jennifer L. Brown, Director, Global Chemistry, Manufacturing & Controls, Pfizer

  • David Lowndes, Head of Small Molecule Operations, Shire Pharmaceuticals

  • Marla Phillips, Director, Xavier Health, Xavier University

Unlocking End-to-End Supply Chain Success


  • Mandy Bosse, Site Head, Patheon

  • Julie Brautigam, Head of Procurement Risk, Sustainability, Performance & Innovation, Takeda Pharmaceuticals

  • Elaine Shannon, Senior Director - Global Quality Compliance and Systems Knowledge Management, Takeda Pharmaceuticals

You Have No Leverage? Now What?


  • Dale Carter, Head of Quality, Business Line Silica, Region North America, Evonik

  • Christina Markus, Partner, King & Spalding

  • David Nowak, Quality Assurance Supplier Manager, AstraZeneca