APEC Supply Chain Security Toolkit

Presenters:

  • 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

Presenters:

  • 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

Presenters:

  • Michael Shepherd, AI Research Technologist, Dell EMC

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


Day 2 Opening

Presenter:

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


FDA Investigator Case Study Insights

Presenters:

  • 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  

Presenter:

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


Global Trade Compliance and Successful Practices

Presenters:

  • 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?

Presenters: 

  • 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

Presenter:

  • Ajay Pazhayattil, Industrial Pharmacist


New Legislation and the Impact to Your Product Approvals

Presenter: 

  • Christina Markus, Partner, King & Spalding


Regulatory Strategy for Supply Chain Success

Presenters:

  • 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

Presenters:  

  • 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

Presenters:  

  • 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”

Presenters:

  • 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

Presenter:

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


TPLC Playbook: Putting the Lifecycle Matrix in Action

Presenters: 

  • 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

Presenters:

  • 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?

Presenters:

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

  • Christina Markus, Partner, King & Spalding

  • David Nowak, Quality Assurance Supplier Manager, AstraZeneca