After a successful first day, the 2015 ISPE/FDA/PQRI Quality Manufacturing Conference is off to a great start. Thought provoking presentations centered on improving manufacturing quality encouraged the buzzing conversations throughout the exhibit hall, session rooms and hallways. We are certain Day Two will continue to foster dialogue to impact the industry and quality initiatives at your company.

Today begins with the Breakfast with the Investigators. Back by popular demand, this session offers the opportunity speak with FDA front-line investigators Jonathon Chapman, Consumer Safety Officer, FDA/ORA/OGROP. Milind Ganjawala, Branch Chief, FDA/CDER/OC/OMQ and Brooke Higgins, Senior Policy Advisor, FDA/CDER/OC/OMQ.

Following the Breakfast, Andy Skibo, Head of Global Biologics Operations and Global Engineering, MedImmune/AstraZeneca, will present his keynote address, “Supply Chain Risk Management.” The three tracks will then break for sessions followed by lunch in the exhibit hall and afternoon sessions. A few key sessions to attend today are:

Track I: Modernization in Manufacturing

Key Elements in Drug Shortages Prevention

  • Gap Analysis – Bryan Wright, ISPE Regulatory Advisor, WorkingWright Ltd
  • Regulatory – Paul D’Eramo, VP Pharma Regulatory Compliance, Johnson & Johnson
  • Training – Christopher Reid, CEO, Integrity Solutions
  • Conferences – Peter Bigelow, President, XCell Strategic Consulting, LLC
  • Alliance/Partnerships – Steve Mahoney, PhD, Senior Director, Global Quality & Compliance, Genentech, Inc.
  • Communications – Thomas Hartman, Vice President, GPM Operations, GlaxoSmithKline
  • Panel Discussion with Session Speakers and Joe Famulare, VP, Global Compliance and External Collaboration, Pharma Technical Quality, Genentech (A Member of the Roche Group); Thomas Hartman, Vice President of GMP Operations, Biopharm CMC, GlaxoSmithKline; Capt. Valerie Jensen, RPh, Associate Director, Drug Shortage Program, FDA/CDER/OCD/DSS; Francois Sallans, VP Quality & Compliance, Chief Quality Officer, Janssen
  • Manufacturing Modernization: Old Facilities + New Tech with David Marks, P.E., Principal, DME Alliance Engineering Consultants, USA

Track II: Regulatory Insights

  • Advancing Risk Management Concepts in Accelerated Drug Applications with Eric Thostesen, Senior Director of Regulatory Compliance, Janssen Pharmaceutical Company Inc.
  • Knowledge and Risk Based Strategies for Lifecycle Management: An FDA Perspective with Christina Capacci-Daniel, PhD, Consumer Safety Officer, FDA/CDER/OPQ/OPF/DIA/IABII

Track III: Quality Systems

  • Product Tracing and Identification under the Drug Supply Chain Security Act with Connie Jung, Pharmacologist, FDA/CDER/OC/ODSIR
  • Holistic Approach to Strengthen Data Integrity with Peter Carbone, Vice President, Novartis Pharmaceuticals

Day Two concludes with the 2015 Facility of the Year Awards Reception and Banquet. ISPE will celebrate and honor the 2015 Category Winners: Astellas Pharma, Inc. (Equipment Innovation), AstraZeneca China (Project Execution), IDT Biologika (Facility Integration) and Pharmalucence, a Sun Pharma Company (Honorable Mention).

We hope you are just as excited as we are for today’s education, networking opportunities and 2015 Facility of the Year Awards Reception and Banquet. Feel free to comment below about what you are most looking forward to in today’s lineup, and be sure to follow the conversation during the conference on iSpeak and Twitter using the hashtag #ISPEQMC.

We look forward to seeing you today in sessions and the exhibit hall.

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