Top Quality Manufacturing Issues Addressed by Regulators & Pharma Experts

ISPE announced its 2018 Quality Manufacturing Conference, taking place 4 – 6 June in Arlington, Virginia USA. Broad regulatory involvement throughout this signature conference makes it the ideal setting for pharmaceutical professionals to gain a clear understanding of current regulatory perspectives on quality manufacturing topics—including quality agreements, API starting materials, human error prevention, contamination control, and patient-centric specification.

“Our program committee is very passionate about quality initiatives and making sure we're doing the right things to manufacture high-quality drugs. We are working very closely with our regulatory colleagues to identify cutting-edge topics and concepts related to GMP for global supply and future possibilities.”
Timothy Watson Timothy Watson, PhD
Program Chair
Senior Director, GCMC Advisory Office Pfizer, Inc

This event will feature global industry experts and regulators, including:

  • Barbara Allen, PhD, Senior Director for Global Quality Systems, Eli Lilly and Company
  • Elizabeth Blackwood, Chief Quality Officer, Johnson & Johnson
  • Jane Chang, PhD, Branch Chief, CDER/OPQ
  • Patricia Hughes, PhD, Consumer Safety Officer
  • Robert Iser, Vice President, Regulatory Consulting Services, PAREXEL International
  • Charles Jewell, CMC Reviewer, OPQ/ONDP/DNDAPI/NDBI
  • Paula Katz, J.D., Supervisory Consumer Safety Officer
  • Stephen Miller, PhD, CMC-Lead, Center for Drug Evaluation and Research, PQ/ONDP/DNDPI/NDPBIII
  • Daniel Peng, PhD, Director, Drug Product Manufacturing Science and Technology, Shire
  • Giuseppe Randazzo, Acting Office Director, OPQ/ONDP

View Agenda

The Quality Manufacturing Conference will be held as part of three key events recognizing the pharmaceutical and biopharmaceutical industry’s efforts to improve product quality and patient health during the 2018 ISPE Pharmaceutical Quality Week. This week will also feature the Continuous Manufacturing Workshop focusing on manufacturing technologies and regulatory approaches for successful development, implementation, and lifecycle management. In addition, five in-depth pharma training courses will be offered: biopharmaceutical manufacturing facilities, GAMP® 5, oral solid dosage (OSD), Quality by Design (QbD), and commissioning and qualification (C&Q).

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