ISPE/FDA/PQRI Quality Manufacturing Conference, 5-7 June, Marriott Crystal Gateway Hotel, Arlington, VA

Education Agenda

Keynote and General Sessions

Opening Keynote Session
Monday, 5 June 0845 - 1100


Education Session: Workshop Introduction
Monday, 5 June 1145 - 1215

  • Timothy Watson, PhD, Research Fellow / CMC Advisory Office, Pfizer Inc, USA
    Workshop Introduction

Women in Pharma Breakfast Program
Tuesday, 6 June 0730 - 0815

In this panel discussion, women leaders from across the pharmaceutical industry will share their leadership and learning journeys. Each panelist will relate how they focused on their strengths and learned from their failures to successfully contribute to the pharmaceutical industry and their own personal career. All conference attendees are welcome!

  • Eileen Brett, Senior Director, Large Molecule Portfolio Management, Janssen R&D, USA
  • Tammie Champlin, Senior Director Quality Engineering, Johnson & Johnson, USA
  • Anna Gilbert, Director, Quality Assurance, Nohla Therapeutics, Inc., USA
  • Valerie Jensen, CAPT, RPh, Associate Director, Drug Shortage Staff, US Food and Drug Administration, USA
  • Nandita Kamdar, PE, Director, Project Management, Johnson & Johnson, USA
  • Georgia Keresty, PhD, VP and Global Head, Pharmaceutical Development & Manufacturing Sciences, Janssen Pharmaceutical, USA
  • Lori Lawless, Program Analyst, US Food and Drug Administration, USA
  • Shannah Schodle Falcone, Associate/Director, Strategic Accounts, CRB, USA
  • Kellie Schoolar-Reynolds, PharmD, Deputy Director, OTS/OCP/DCPIV, US FDA, Center for Drug Evaluation and Research, USA
  • Mihaela Simianu, PhD, Director Regulatory Compliance, Pharmatech Associates, Inc., USA
  • Susan Stipa, President, McDay Technical Marketing LLC, USA
  • Emily Stump, Director of Operations, Pacific Northwest, Commissioning Agents, Inc., USA
  • Jennifer Clark, CPIP, Executive Director, Strategic Development, Commissioning Agents, Inc, USA
  • Joyce Hansen, Vice President, Sterility Assurance, Johnson & Johnson, USA
  • Frances Zipp, President & CEO, Lachman Consultant Services, USA

Industry Keynote Session
Tuesday, 6 June 0830 - 1000


Featured Session: Interactive Discussion on Drug Shortage Prevention
Tuesday, 6 June 1500 - 1600

Hear the latest developments in drug shortages prevention. The discussion will help all become current on the most recent activities of ISPE and the Industry and discuss ways to further help industry to eliminate or minimize drug shortages.

  • Leader: François Sallans, PharmD, VP Quality & Compliance, Chief Quality Officer, Johnson & Johnson, USA
    Drug Shortages: The Remaining Challenge
  • Valerie Jensen, CAPT, RPh, Associate Director, Drug Shortage Staff, US Food and Drug Administration, USA

Featured Session: Data Integrity
Tuesday, 6 June 1500 - 1600

This session will provide a recap of the ISPE Data Integrity Workshop held on Sunday, June 4th. It will include an overview of the ISPE GAMP Records and Data Integrity Guide just released in April 2017, as well as the key learning points and take away ideas from the DI Workshop. The session will conclude with an opportunity to ask and discuss DI related questions and concerns.

  • Michael Rutherford, Consultant - Laboratory and Quality Systems, Eli Lilly and Company, USA
    Data Integrity

Featured Session: Emerging Therapeutic Entities in Immunotherapy and Gene and Cell-Based Therapies
Tuesday, 6 June 1500 - 1600

Sponsored by the ISPE Women in Pharma Initiative

This session is part of the continuing education commitment of the Women In Pharma Team (WIP). WIP’s mission is to provide women in the pharmaceutical industry a forum for connecting and collaborating on technical and career advancement topics. A community of WIP mentors, resources across all levels, and educational sessions will be an enabler for career success.

In this session WIP would like to bring attention of the audience to emerging therapeutic entities in immunotherapy, gene and cell-based therapies. Session will be focused on science, technology and processes to bring such innovative products and advances in precision medicine to respond the healthcare needs. All pharmaceutical professionals are invited to attend. This session will be led by a key member of the ISPE WIP team, Mihaela Simianu, Ph.D, Directory of Regulatory Compliance at Pharmatech Associates, Inc. and will include speakers from representative pharmaceutical companies.


FDA Keynote Session
Wednesday, 7 June 0830 - 1000


Workshop Outcomes and Next Steps
Wednesday, 7 June 1015 - 1110

  • Steven Greer, Corporate QA External Engagement Leader, Procter & Gamble, USA
    Quality Metrics Workshop Summary
  • John Lepore, PhD, Senior Director, Chemical Engineering, Merck & Co Inc, USA
    Emerging Technology & Innovation Workshop Output
  • James McGlade, Science Client Leader, BHDP Architecture, USA
    Lifecycle Quality Management Workshop Summary
  • Daniel Peng, PhD, Senior Principal Scientist/Director, Shire, USA
    Clinical Relevance
  • George Millili, PhD, Senior Principal Technical Advisor, Genentech, USA

Regulatory Round Table & Closing Presentation
Wednesday, 7 June 1115 - 1215

Session Moderators:


  • Rapti Madurawe, PhD, FDA Conference Co-Chair, Director (Acting) Division of Process Assessment I, FDA/CDER/OPQ

  • ISPE North American Focus Group, Regulatory Compliance Committee (RCC):

    • Charles Hoiberg, PhD, Executive Director, Pfizer Inc.

    • Eric Thostesen, Senior Director, Regulatory Compliance, Johnson and Johnson, Inc.

    • Timothy Watson, PhD, Research Fellow/CMC Advisory Office, Pfizer Inc.

  • Sharmista Chatterjee, PhD, Division Director, OPF, and Emerging Technology Team Member, FDA/CDER/OPQ/OPF/DPAII, USA
  • Thomas Cosgrove, JD, Director, Office of Manufacturing Quality, FDA/CDER/OC, USA
  • Richard Friedman, Deputy Director, Science and Regulatory Policy, FDA/CDER/OC/OMQ, USA
  • Jennifer Maguire, PhD, Division Director (Acting), Office of Surveillance, FDA/CDER/OPQ,
  • George Millili, PhD, Senior Principal Technical Advisor, Genentech, USA
    Next Steps for Quality Manufacturing
  • Helen Saccone, CDR, PharmD, Associate Director, Global Regulatory Policy, FDA/OC/OGROP, USA
  • Paul Seo, PhD, Director (Acting), Division of Biopharmaceutics, FDA/CDER/OPQ/ONDP, USA
  • Rakhi Shah, PhD, Branch Chief (Acting), Office of Process and Facilities, FDA/CDER/OPQ, USA
  • Charles Hoiberg, PhD, Executive Director, Pfizer, USA
  • Rapti Madurawe, PhD, Director, Division of Process Assessment I, FDA/CDER/OPQ, USA
  • Eric Thostesen, Senior Director Regulatory Compliance, Johnson & Johnson, Inc., USA
  • Timothy Watson, PhD, Research Fellow / CMC Advisory Office, Pfizer Inc, USA

Core Workshop Topics with FDA and
Pharmaceutical Industry Facilitators

Clinical Relevance Workshop

Linking Quality to Clinical Relevance (Rotation 1)
Monday, 5 June 1315 - 1445

Regulatory and industry have been exploring how clinically relevant specifications (CRS) might be of value with regards to patience safety. Varying positions on these topics have proposed, for example, intentionally adding variability into clinical trials, setting specifications based on limited batch data and/ or commercial manufacturing experiences, or how ICH guidance based safety projections should be utilized, etc. Questions remain on the extent of CRS boundaries related to experience in the clinic and commercial scale, defining the degree of risk, and/ or would CRS be more relevant over the product lifecycle. This workshop will engage participants to incorporate their experiences and to propose solutions.
Pre-Conference Reading: http://www.sciencedirect.com/science/article/pii/S0378517315004950
Objectives of the Workshop:

  • Develop new ways of thinking in setting drug substance and drug product specifications
  • Educate and share industry and global regulatory agency of the risk and impact to public health and business on non-clinically relevant specifications
  • Facilitate pharmaceutical/Biotech industry to implement the tools/ strategy to achieve CRS for future drug products.

Workshop Facilitators

  • Susan Berlam, RPh, Senior Director Regulatory CMC, Pfizer Inc, USA
  • Shrinivas Murti, PhD, Director, Global Regulatory CMC, Merck & Co Inc, USA
  • Daniel Peng, PhD, Senior Principal Scientist/Director, Shire, USA
    Workshop: Linking Quality to Clinical Relevance
  • Sarah Pope Miksinski, PhD, Director, Office of New Drug Products, Director (Acting) Office of Surveillance, FDA/CDER/OPQ, USA
  • Paul Seo, PhD, Director (Acting), Division of Biopharmaceutics, FDA/CDER/OPQ/ONDP, USA

Linking Quality To Clinical Relevance (Rotation 2)
Monday, 5 June 1545 - 1700


Linking Quality To Clinical Relevance (Rotation 3)
Tuesday, 6 June 1045 - 1200


Linking Quality To Clinical Relevance (Rotation 4)
Tuesday, 6 June 1300 - 1415


Emerging Technology & Innovation Workshop

Modernizing Pharmaceutical Manufacturing through Emerging Technology and Innovation (Rotation 1)
Monday, 5 June 1315 - 1445

New and even existing products often benefit from the implementation of new commercial manufacturing technologies. With the FDA’s new guidance on emerging technologies, the pharmaceutical industry is embracing the opportunity to bring new technologies to life to support robust manufacturing of products. However, the pharmaceutical industry is a global business and manufacturing technologies of this type must be globally accepted.

Objectives of the Workshop:

  • Share concerns and perspective on the implementation of new technologies
  • Explore the how control strategies might be similar and/or different between traditional and new technologies
  • Learn and share industry success stories and identify possible new opportunities and best practices. Explore the new FDA Emerging Technologies Team Website

Workshop Facilitators

  • Sharmista Chatterjee, PhD, Division Director, OPF, and Emerging Technology Team Member, FDA/CDER/OPQ/OPF/DPAII, USA
  • Gabriella Dahlgren, PhD, Manager, Analytical Sciences & Technology, Advanced Analytics & Design To Value, Janssen Supply Group LLC, USA
  • John Lepore, PhD, Senior Director, Chemical Engineering, Merck & Co Inc, USA
    Workshop: Modernizing Pharmaceutical Manufacturing through Emerging Technology and Innovation
  • Frank Montgomery, PhD, Global Head, Regulatory CMC, AstraZeneca, United Kingdom

Modernizing Pharmaceutical Manufacturing through Emerging Technology and Innovation (Rotation 2)
Monday, 5 June 1545 - 1700


Modernizing Pharmaceutical Manufacturing through Emerging Technology and Innovation (Rotation 3)
Tuesday, 6 June 1045 - 1200


Modernizing Pharmaceutical Manufacturing through Emerging Technology and Innovation (Rotation 4)
Tuesday, 6 June 1300 - 1415


Facility & Lifecycle Quality Management Workshop

Designing Proactive Approaches to Facility and Lifecycle Quality Management (Rotation 1)
Monday, 5 June 1315 - 1445

Operation and maintenance of a compliant and robust pharmaceutical facility day to day is complex. Facility systems, utilities, equipment, qualifications and preventive maintenance processes have a large impact on the quality and robustness of the finished product. A holistic Lifecycle approach to process and facility maintenance will help prevent drug shortages, costly recalls etc. This session will discuss state of the art best practices for operating a facility, its systems and equipment. This session will allow you to hear and share best practices in this area and how companies maintain their facilities and processes in a state of control.

Objectives of the Workshop:

  • Share and debate best industry practices for holistic Lifecycle approaches for maintaining your facilities and processes in a state of control
  • Explore optimal ways to assure your processes key parameters remain in a state of control (i.e. Process Monitoring capability and control, Continuous Process Verification etc...)
  • To blend in Quality, scientific and engineering aspects of your facility and processes

Workshop Facilitators

  • James McGlade, Science Client Leader, BHDP Architecture, USA
    Workshop: Proactive Approaches to Facility and Lifecycle Quality Management
  • Jennifer Mitchell, Senior Manager, Validation Engineering, Biogen, USA
  • Rakhi Shah, PhD, Branch Chief (Acting), Office of Process and Facilities, FDA/CDER/OPQ, USA
  • Jennifer Walsh, Director Robustness & Validation, Bristol-Myers Squibb, USA

Designing Proactive Approaches to Facility and Lifecycle Quality Management (Rotation 2)
Monday, 5 June 1545 - 1700


Designing Proactive Approaches to Facility and Lifecycle Quality Management (Rotation 3)
Tuesday, 6 June 1045 - 1200


Designing Proactive Approaches to Facility and Lifecycle Quality Management (Rotation 4)
Tuesday, 6 June 1300 - 1415


Quality Metrics Workshop

Implementing Next Steps for Quality Metrics (Rotation 1)
Monday, 5 June 1315 - 1445

The FDA Draft guidance on Quality Metrics is was reissued considering industries comments on the first draft. Now what? ISPE has been leading the charge in bringing the pharmaceutical industry and regulators together to create an open dialogue on shaping the Quality Metrics program as it is launched industry wide. However, industry is struggling with the “how” and options for implementation in dialogs with FDA. This is your opportunity to engage in open and honest dialog on potential next steps for this proposed guidance and how it might be impacting your company and the pharmaceutical industry.

Objectives of the Workshop:

  • Share concerns and alternate perspectives on the implementation of quality metrics
  • Explore the value statement, risk, and impact to commercial manufacturing
  • Facilitate pharmaceutical/Biotech industry sharing of implementation strategies, experiences, and challenges

Workshop Facilitators

  • Betsy Fritschel, Director Quality & Compliance, J & J Enterprise Regulatory Compliance, USA
  • Steven Greer, Corporate QA External Engagement Leader, Procter & Gamble, USA
    Workshop: Next Steps for Quality Metrics
  • Jennifer Maguire, PhD, Division Director (Acting), Office of Surveillance, FDA/CDER/OPQ,
  • Sarah Pope Miksinski, PhD, Director, Office of New Drug Products, Director (Acting) Office of Surveillance, FDA/CDER/OPQ, USA
  • Bryan Winship, Sr. Director Global Quality Risk Management, Mylan, USA

Implementing Next Steps for Quality Metrics (Rotation 2)
Monday, 5 June 1545 - 1700


Implementing Next Steps for Quality Metrics (Rotation 3)
Tuesday, 6 June 1045 - 1200


Implementing Next Steps for Quality Metrics (Rotation 4)
Tuesday, 6 June 1300 - 1415


Schedule-at-a-Glance

Monday 05 June 2017

08.30–11.00 Opening Keynote Session
11.00–11.45 Networking Break
11.45–12.15 General Education Session
12.15–13.15 Lunch
13.15–14.45 Concurrent Workshops
14.45–15.45 Networking Break
15.45–17.00 Concurrent Workshops
17.00–18.30 Networking Reception in the Exhibit Hall

Tuesday 06 June 2017

07.30–08.15 Women in Pharma Program
08.30–10.00 Industry Keynote Session
10.00–10.45 Networking Break
10.45–12.00 Concurrent Workshops
12.00–13.00 Lunch
13.00–14.15 Concurrent Workshops
14.15–15.00 Networking Break
15.00–16.00 Featured Sessions
18.30–21.30 2017 FOYA Awards Reception & Banquet

Wednesday 07 June 2017

08.30–10.00 FDA Keynote Session
10.00–10.15 Networking Break
10.15–11.10 Workshop Presentations
11.15–12.30 Regulatory Round Table and Closing Presentation

Event Sponsors

Presentations & Attendee Roster

Conference Attendees:


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