2013 Annual Meeting

Pharmaceutical Quality Systems

Education Session: Executive Series - The FDASIA Transition Point for Pharmaceutical Quality Systems (PQS) and cGMP

Tuesday, 5 November 2013, 8:00-11:30

Richard Friedman
Associate Director, CDER/OC/OMPQ, FDA

Joseph Famulare
VP Compliance and External Relations, Genentech
Rapporteur ICH Q 10 Pharmaceutical Quality Systems

The FDASIA Transition Point for Pharmaceutical Quality Systems (PQS) and cGMP

  • Learn what Constitutes a cGMP-compliant Pharmaceutical Quality System
  • How will you Establish Oversight and Control Required by FDASIA?
  • How has ICH Q10 influenced cGMP?

In the FDASIA provisions enacted by Congress in 2012, the legislation states the term “current good manufacturing practice” includes the implementation of oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products.

This session will explore how FDA is looking at Pharmaceutical Quality Systems and the Role of Senior Management in pharmaceutical quality and cGMP implementation since the passage of FDASIA. This session will reveal FDA’s latest thinking on the topic now as the Agency continues to implement the Drug Safety provisions of FDASIA. Understand why it is necessary to have an effective quality system in order to have one that is cGMP compliant. Learn the effects that the implementation of a Pharmaceutical Quality System have had from an industry perspective since the FDA and ICH guidelines have published, and the FDASIA GMP requirement for proper management oversight. In this important session, learn:

  • Benefits realized from PQS
  • What is a GMP-compliant Quality System?
  • Additional learnings about Quality Systems and its importance from the ISPE Drug Shortage Survey, as a way of mitigation
  • FDA’s expectations for Senior management as part of Quality system implementation
  • Managing risks, in general, with the deeper goal of exemplifying how this can establish safety of raw materials, drugs at intermediate stage, and finished products
  • How this will be further implemented via FDASIA


Richard Friedman U.S. FDA, CDER, OMPQ, Associate Director, Co-Chair FDA Quality Systems Workgroup

  • FDA’s Next Steps for Quality Systems for Pharmaceuticals following FDASIA

Bob Sausville U.S. FDA, CBER, Director Case Management, Office of Compliance, Co-Chair FDA Quality Systems Workgroup

  • How FDA Communicates expectations for the Implementation of Quality Systems via its cGMP Inspection Compliance programs and via Regulatory Communications with Firms

Joseph C. Famulare, VP, Global Compliance & External Collaboration, Genentech

  • Benefits of Implementation for an Industry Standpoint of PQS, how quality systems informed the ISPE drug survey

Barbara Allen, Ph.D., Senior Director, Global Quality Systems, Eli Lilly

  • How management uses PQS to ensure consistent operations and reliable supply, and as a risk Mitigation strategy

Zena G. Kaufman, SVP Quality, Hospira Inc. (invited panelist)

Learning objectives

  • Understanding the 2012 FDASIA legislation in order to incorporate these requirements into your quality system and cGMP implementation at your company
  • See how industry has implemented PQS since Q10 has published. Have global organizations reaped quality or business advantages by implementing more robust management systems?
  • Discuss what opportunities do regulators see for harmonization and in working in the global supply manufacturing network
  • Understand how the risk management provisions will be implemented by industry and evaluated by regulators
  • Understand the role of senior management in exercising “oversight and control” of manufacturing and quality. How do you conduct a Quality System review, and how can metrics be used in these reviews? Discuss and learn how various features of the Quality System interact to form a robust quality assurance program.
  • Will FDA update the cGMPs? Hear and discuss those possibilities.
  • FDA has announced the need to update its 2006 Quality Systems Guidance. What are some ideas and feedback that would provide clarity to industry and regulators  to make this FDASIA provision effective

Who should attend?

  • Manufacturing
  • Development
  • Supply Chain
  • Development
  • Regulatory
  • Engineering
  • Managers Directors Officers
  • Distributors
  • Sponsors
  • CMOs
  • Transportation 
  • Warehousing
  • Security Personnel
  • Domestic and International Companies and Regulators
  • Analysts
  • Operator Personnel

Quality Metrics Outcomes: Conversations with the FDA

Monday, 4 November 2013, 14:00-17:30

Continuing the success of the Quality Metrics workshops at the ISPE/FDA CGMP Conference in June 2013, this session will present the next phase in this critical conversation between industry and regulators. The session will open with an update from Russ Wesdyk, OSP Scientific Coordinator, FDA on where the FDA stands in regard to Quality Metrics and what they perceive to be the critical factors to engaging and preparing the pharmaceutical industry. Pending the development of the OPQ that Janet Woodcock has envisioned this initiative could have an immediate and extensive impact on your daily procedures. Presentations from the ISPE Quality Metrics working groups on potential metrics for Batch Failure Rates, OOS/Lab Failure Rates, and Leading Quality Metrics and New Ideas will be on the agenda. This is your opportunity to ask questions directly of the experts navigating this very important development. The tangible outcome of the session will be a white paper to be presented to the FDA as a recommended path forward. Don’t miss this opportunity to shape your industry!


Russ Wesdyk, Science Coordinator, FDA

  • FDA Update and the Progression towards Mutual Benefits

Cindy Salamon, VP, Global Quality Services, Bristol-Myers Squibb, USA

  • Out of Specification / Laboratory Failure Investigation Rates
  • Highlights, Updates and a Path Forward

Lorraine McClain, Senior Director Quality Compliance, Teva Pharmaceuticals

  • Batch Failure Rate

Lorraine Thompson, Quality Systems Implementation Director, Novartis, USA

  • Leading Quality Metrics and New Ideas

Who Should Attend?

  • Manufacturing
  • Operations
  • Development
  • Supply Chain
  • Research
  • Regulatory
  • Engineering
  • Managers Directors Officers
  • CMOs
  • Domestic and International Companies and Regulators
  • Analysts

Continue the conversation with industry leaders and invited regulator on Tuesday Morning from 7:00am – 8:00am in Maryland I, Lobby Level. Limited seating available, please sign-up during the Quality Metrics Session on Monday Afternoon from 14.00 – 17.30 Washington 6, Exhibition Level.

Regulators Invited

  • Rick Friedman
  • Francis Godwin
  • Karthik Iyer
  • Alex Viehmann
  • Russ Wesdyk

Thank you to our Top Tier Sponsors

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