Welcome to the 2015 ISPE/FDA/PQRI Quality Manufacturing Conference! We are excited to start the day with keynote presentations by Juan Andres, Head Pharma Tech Ops, Novartis Pharma AG and Janet Woodcock, M.D., Director, CDER, FDA/CDER/OCD.

In his presentation, “Innovative Manufacturing Promotes Quality,” Andres will discuss creating a culture of “Quality beyond Compliance” to reach new levels of reliability. Dr. Woodcock will follow with her presentation about FDA’s Quality Initiatives.

After the keynote, the ISPE Quality Metrics Team will discuss the outcomes of the ISPE Quality Metrics Summit and the final data of the ISPE Quality Metrics Pilot Report.

Education will break following the Quality Metrics session for lunch in the exhibit hall giving you the opportunity network with exhibitors. The afternoon will be filled with education sessions in three tracks: Modernization in Manufacturing, Regulatory Insights and Quality Systems. Some of today’s presentations of interest include:

Track I: Modernization in Manufacturing

  • Continuous Pharmaceutical Manufacturing: Quality-by-Design, Systems Integration, and Control with Richard Braatz, Ph.D., Edwin R. Gilliland Prof of Chemical Engineering, Novartis-MIT Center for Continuous Manufacturing
  • Changing the Pharmaceutical Industry Paradigm: Portable, Continuous, Miniature & Modular Development and Manufacturing with Phillip Nixon, PhD, Executive Director and Drug Product Technology & Innovation Lead, Pfizer Inc.

Track II: Regulatory Insights

  • Get Up and Dance: Launching a Process Capability Program in a Global Manufacturing Network with Aaron Goerke, PhD, Global MSAT Sr. Group Leader/Principal Engineer, Genentech Inc., A Member of the Roche Group
  • Variation is the Enemy:  Practical Tools for Identifying and Reducing In-Process Variation with Mike Reske, Quality Engineering Manager, Perrigo Company PLC

Track III: Quality Systems

  • Business Across Borders:  The Impact of Culture on Quality with Dana Blobner, Director Quality Assurance, Ultragenyx Pharmaceutical Inc.
  • An Operational Excellence Thinking Model with Mark Swatling, Senior Director Operational Excellence, AstraZeneca

Day One of the conference concludes with a networking reception in the exhibit hall where you can meet with international exhibitors, industry leaders and regulators. Don’t forget to follow the conversation during the conference on iSpeak and Twitter using the hashtag #ISPEQMC.

We look forward to seeing you today.