Pharmaceutical Serialization Workshops, 8-9 May, Sonesta Philadelphia, Rittenhouse Square, Philadelphia PA

Serialization Workshops Education

Join regulators and leading pharmaceutical industry experts from the U.S. and Europe for this unique event. This interactive conference includes two keynote sessions, two industry panel discussions, 10 workshops, and other peer-to-peer knowledge sharing opportunities.

The workshops are in two tracks, focused on practical readiness and operationalization issues as well as more advanced topics to support companies in maximizing their assets across global supply chains.

Daily Schedule and Workshop Topics

Bookmark this page for ongoing program and speaker updates.

Monday, 8 May

08:30 - 10:30  Opening Keynote Session: Effectively Operationalizing Your Serialization Program
  • Lars Olsen, Global Technology Partner, NNE, Denmark
    Global Serialization Overview and Trends
  • Bryan Orton, Director, Eli Lilly & Co, USA
    Managing Serialization After the Line is Ready
  • Thomas Pizzuto, Global Process Owner, Product Serialization & Traceability, Johnson & Johnson Supply Chain, USA
    The Johnson & Johnson Experience
10:30 - 11:00  Networking Break
11:00 - 12:20  W1: Featured Workshop
  • Portability and Interconnectivity of Data
    • Dennis Even, Global Serialization PMO / BT Lead, PGS & Finance BT, Pfizer, USA
      Interconnectivity of Data
    • Richard Mitzner, Retired (former Senior Director, Engineering Technology, Pfizer Inc.), USA
      Managing Serialization Master Data from Enterprise Applications through Packaging Line Control
12:20 - 13:20  Lunch
13:20 - 14:40  W3: Operationalizing Serialization- Systemic Planning for Implementation
  • Elliot Abreu, Senior Vice President, Xyntek Inc., USA
    Keep Calm & Serialize On™… Keys to a Successful Serialization Project
  • Mario Simard, Director Product Line Management, Optel Vision, Canada
    Packaging Line Deep-dive: What is the impact of serialisation on your packaging sites, how to prepare yourself.
13:20 - 14:40  W2: Global Issues, Perspectives, and Case Studies on Readiness, Planning, Implementation, and Harmonization to Ensure Product Protection
  • Arjun Guhathakurta, Life Science Director - Operations, CONVAL GROUP, India
    Lessons Learned from Serialization Issues in India
  • Timur Kabadayi, Managing Director, CONVAL Group, Turkey
    Lessons Learned from Turkey’s Pharma Industry Experience with Serialization Launch and Implementation
14:40 - 15:10  Networking Break
15:10 - 16:30  W4: Perspectives on Managing Serialization: Management, Planning, Communication, and Business Issues: Benefits/Possible Risks Beyond Serialization
  • Randolph Leinhauser, Associate Director, Engineering, Merck, USA
  • Chuck Sailer, Serialization Expert, Adents, USA
    Site-Level or Corporate Level Serialization Solutions: How to Define Your Needs
15:10 - 16:30  W5: Shop-Floor Tactics to Prevent and Address Defects
  • Patrick Boyle, President and CEO, Skillpad Canada Inc., SKILLPAD Canada Inc., Canada
    Situational Awareness: Operator Readiness, Training, and Lessons from Other Industries
  • Ryan Pease, Associate Consultant Engineer, Eli Lilly & Co, USA
    Preventing and Addressing Serialization Related Defects
16:30 - 17:15  Recap of Key Issues: Industry Panel Discussion and Q/A
  • Elliot Abreu, Senior Vice President, Xyntek Inc., USA
  • Patrick Boyle, President and CEO, Skillpad Canada Inc., SKILLPAD Canada Inc., Canada
  • Dennis Even, Global Serialization PMO / BT Lead, PGS & Finance BT, Pfizer, USA
  • Arjun Guhathakurta, Life Science Director - Operations, CONVAL GROUP, India
  • Timur Kabadayi, Managing Director, CONVAL Group, Turkey
  • Randolph Leinhauser, Associate Director, Engineering, Merck, USA
  • Richard Mitzner, Retired (former Senior Director, Engineering Technology, Pfizer Inc.), USA
  • Ryan Pease, Associate Consultant Engineer, Eli Lilly & Co, USA
  • Chuck Sailer, Serialization Expert, Adents, USA
  • Mario Simard, Director Product Line Management, Optel Vision, Canada
  • Moderator: Robert Matje, CPIP, PE, Principal, RemTech, LLC, USA
  • Moderator: Andrea Zoppi, PhD, Global Quality Systems - Packaging and Labeling Consultant, Eli Lilly Italia SpA, Italy
17:15 - 18:15  Networking Reception

Tuesday, 9 May

08:30 - 10:10  General Session: Connecting the Dots Beyond Compliance - Global Supply Chain Product and Patient Protection - Regulatory Perspectives
  • Richard Andrews, Unit Manager, Inspectorate Operations, MHRA, United Kingdom
    Falsified Medicines Directive: Safety Features for Medicinal Products for Human Use
  • Connie Jung, PhD, Senior Advisor for Policy, FDA/CDER/OC, USA
10:10 - 10:40  Networking Break
10:40 - 12:00  Perspectives on Managing Serialization - Part 2: Managing Complex Serialization Progress: From Conceptual Design to Deployment and Beyond
  • Adriano Fusco, Global Strategy & Development Director, Antares Vision/Director, OPEN SCS, Italy
12:00 - 13:00  Lunch
13:00 - 14:20  W8: Current and Future Serialization Standards and Requirements
  • Adriano Fusco, Global Strategy & Development Director, Antares Vision/Director, OPEN SCS, Italy
    Working for an Open Standard for Data Exchange in Serialization
  • John Hartwig, Co-Founder, Rem Tech LLC, USA
    Global Serialization Requirements and What They Mean for Your Company
13:00 - 14:20  W7: Coordination with Suppliers, CMOs, and Other Stakeholders
  • Graham Clark, Director, Worldwide Channels, TraceLink, USA
    Preparing your External Manufacturing Network for Global Serialization
  • Victor Virginio, Director of Engineering, Sharp Packaging Solutions, USA
14:20 - 14:50  Networking Break
14:50 - 16:10  W10: Hidden Problems, Hidden Benefits of Serialization
  • Terrence Jones, Director, Strategic Manufacturer Services, ICS AmerisourceBergen,
    A 3PLs Perspective on Hidden Problems, Hidden Benefits of Serialization
  • Michael Keech, Head of Business Strategy, Lachman Consultant Services, USA
    The Challenges of Aligning your Quality Management System to Your Serialization Efforts
  • David Lonza, Deputy Advisor To the CEO - Strategic Initiatives, Lachman Consultants, USA
    The Challenges of Aligning your Quality Management System to Your Serialization Efforts
14:50 - 16:10  W9: New Frontiers for Serialization - Emerging Science/Technology Issues to Meet Patient Needs
  • Thomas Mercolino, PhD, President and CEO, Verinetics, USA
    Integrating and Converging Authentication with Serialization
  • Dirk Rodgers, Regulatory Strategist, SYSTECH International, USA
    Brave New World: Risks and Rewards From Pharma Serialization
16:10 - 16:45  Closing Panel Discussion
  • Graham Clark, Director, Worldwide Channels, TraceLink, USA
  • John Hartwig, Co-Founder, Rem Tech LLC, USA
  • Terrence Jones, Director, Strategic Manufacturer Services, ICS AmerisourceBergen,
  • Michael Keech, Head of Business Strategy, Lachman Consultant Services, USA
  • David Lonza, Deputy Advisor To the CEO - Strategic Initiatives, Lachman Consultants, USA
  • Thomas Mercolino, PhD, President and CEO, Verinetics, USA
  • Dirk Rodgers, Regulatory Strategist, SYSTECH International, USA
  • Moderator: Nicholas Davies, Managing Partner, Co-Chair Operations, Management COP , Verta Life Sciences, USA
  • Moderator: Robert Matje, CPIP, PE, Principal, RemTech, LLC, USA

Featured Speakers

Thomas Pizzuto Photograph
Thomas Pizzuto
Global Process Owner, Product Serialization and Traceability
Johnson & Johnson Supply Chain
Bryan Orton Photograph
Bryan Orton
Director, Global Product Protection and Serialization
Eli Lilly and Company
Lars Olsen Photograph
Lars Olsen
Global Technology Partner
NNE
Richard Andrews Photograph
Richard Andrews
Unit Manager Inspectorate Operations GMP and PV
MHRA
Connie Jung, PhD Photograph
Connie Jung, PhD
Senior Advisor for Policy
FDA/CDER/OC

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