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Education Details

Plenary Sessions Breakout SessionsSpecial EventsDrug Shortage Panel

“The information was unbelievably informative, eye opening and relatable to our day-to-day operations and challenges. It was a great experience and opportunity to have an open discussion with the FDA and industry leaders.”

- Michael J. Callahan, Manufacturing Supervisor, Buffer Prep/Alewife, Shire, ISPE 2012 CGMP Conference Delegate

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Plenary Speakers 

 PhotoHoward Sklamberg, J.D.
Director, Office of Compliance, FDA, USA

Vision for Quality

 PhotoAndy Skibo
Regional Vice President, Biologics-Supply, MedImmune/AstraZeneca

Quality Pays for Itself

 PhotoGerald Heddell
Director of Inspection, Enforcement and Standards, MHRA, UK

Supply of Medicines to EU

 PhotoJohn Pinion
Global Head of PT Quality & Compliance, Genentech/F. Hoffman La Roche Ltd.

Leadership's Role in a Culture of Quality

 PhotoJaspreet Gill
Vice President, Global Quality and Compliance, Baxter

Quality Risk Management

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Information-Packed Topics You Can’t Afford to Miss!

Breakout Sessions 

Quality Metrics

Discover breakthrough thinking and participate in discussions aimed at advancing industry-wide change. In this workshop, you'll gain insight into FDA's planned direction, challenges to alignment across industry and a recommended path forward. Gain insight into FDA's planned direction, challenges to alignment across industry and a recommended path forward.    

  • Begin to define metrics that “define” product quality.
  • Discuss other discrete set of metrics that will provide the most value.
  • What are “leading indicators."
  • Learn best practices that are used internally by companies.
  • What will be useful to regulators in making inspection frequency decisions?

Breakout Workshops:

  • Batch Failure Rate – Michael Davidson, Vice President Contract Operations QA, Pfizer, Inc.
  • Right First Time – Lorraine McClain, Senior Director, Quality Compliance, Teva Pharmaceuticals
  • OOS/Lab Failures – Ferdinando Aspesi, Vice President, Senior Advisor, Novartis
  • Potential Leading Metrics – Lorraine Thompson

Moderators: 
Cindy Salamon, Vice President, Global Quality Services, Bristol-Myers Squibb
Russ Wesdyk, OPS Scientific Coordinator, CDER, FDA, Invited

Speakers:

    Leadership in Pharma Quality Management

    • Learn how great companies build and sustain a culture of quality throughout the product lifecycle.
    • Understand leadership behaviors that foster employee commitment to quality.
    • Discover how leading companies promote quality as an imperative, not simply a goal.

    Moderator: 
    Edwin Rivera-Martinez, U.S. Quality Liaison, Global Quality, Sanofi-Aventis

    Speakers:

      Process Performance and Product Quality Monitoring System

      • Establishing a PPPQMS with concepts of process design, tech transfer and monitoring
      • Use of statistics, Control charts and process capability
      • Use of statistical modeling in design and development and maintenance over the lifecycle
      • Use of metrics to understand halt of the product and overall state of control
      • Understand the concept of the Product Quality Steward Model

      NEW! ISPE PQLI Guide Series - Part 4: Process Performance and Product Quality Monitoring System Guide will be available at the conference.

      Moderator: 
      George Millili, PhD., Director, Pharmaceutical Commercialization Technology, Merck & Co, Inc.

      Speakers:

        Quality Management of CMOs

        • Quality perspective on current challenges with CMO activities.
        • How to define your “Critical to Quality” parameters.
        • Use of metrics to monitor the “Critical to Quality” parameters.

        Moderators: 
        Mike Arnold, Senior Director, Strategic Partnerships, Pfizer, Inc.
        Mike Smedley, Acting Director, OMPQ, FDA

        Speakers:

          Basic PAI Readiness Success and Advent of Breakthrough Therapies

          • Discuss readiness for commercial manufacturing.
          • Understand appropriate stage validation.
          • Hear about the role of data integrity.

          Moderator: 
          Joe Famulare, Vice President, Genentech, Inc.

          Speakers:

            CAPA and Lifecycle QRM

            • Understand QRM and CAPA differences and how they interact with the product/system lifecycle.
            • Build and maintain a robust quality system with feedback loops and Human Error Reduction (HER).
            • Gain insight into how CAPA drives quality system improvements.

            Moderator: 
            Steve Tyler, Director Quality Assurance, AbbVie

            Speakers:

              Continually Investing in Your Facilities and Equipment

              • Identify key metrics and indicators for developing facility investment strategies.
              • Incorporate risk-based, periodic monitoring into long-term investment plan.
              • Employ financial analysis of continual re-investment to avoid mandated capital investments.

              Moderator: 
              Tim Howard, Vice President, Operations, Commissioning Agents, Inc.

              Speakers:

                Controlling Pharma Data in the Cloud

                • Rapidly deploy flexible, economical alternatives to building applications through cloud solutions.
                • Meet both internal and regulatory expectations.
                • Explore solutions through case studies for GMP implementation of CAPA and LIMS.

                Moderators: 
                Randy Perez, Director, Information Governance and Management, Novartis
                Krishna Ghosh, Compliance Officer-CDER/Office of Compliance, FDA

                Speakers:

                  Industry Leading Special Events 

                  Meet the Press

                  A distinguished panel of regulators and industry experts will answer questions about how to drive patient safety, product quality and compliance throughout organizations, and how the pharmaceutical industry and regulatory agencies can work effectively in achieving these mutual goals. This thought‐provoking session is intended to open a dialog on issues and future direction and will be driven by industry, agency and audience questions. The expert moderators represent the pharmaceutical industry technical press, business and public media teaming to deliver a high value, engaging discussion.

                  Session Moderators:
                  Jeff Salkin, Host Direct Connect, Maryland Public Television
                  Bill Paulson, Editor-in-Chief, IPQ

                  Panel Members:

                    Industry-Led Hot Topic Discussion Forum

                    Industry leaders will answer questions directly from the audience. This your unique opportunity to have your questions, concerns, needs for clarity and opportunities for collaboration to be addressed directly by industry executives.

                    Session Moderator: 
                    Joe Famulare, Vice President, Genentech, Inc.

                    Speakers:

                      Breakfast with the Inspectors

                      This is an opportunity to hear from regulators and engage in open dialogue with them in a relaxed atmosphere.  The breakfast is included in the cost of event registration and is open to all delegates.  Limited seats available, be sure not to miss this exciting event!

                      Moderator: 
                      Steve Lynn, Senior Advisor to the Assistant Commissioner for Operations, Office of Regulatory Affairs/Office of Operations Immediate Office, FDA

                      Speakers:

                        Drug Shortage Panel Discussion

                        The conference will open with a spirited panel discussion led by the leaders of the committee that spearheaded the survey initiative. The panel will share issues identified using key data from the groundbreaking ISPE Drug Shortage Survey, and then discuss how shortages are impacting the industry. The All Conference Session will focus on potential industry solutions based on new FDA guidance with presentations on:

                        • ISPE Drug Shortage Survey Results
                        • Drug Shortages and the FDA Response

                        Facilitator: 
                        Joe Famulare, Vice President, Genentech, Inc. 

                        Panel Members:

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