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

Education Program

Expect a brand new experience at this year’s conference!

  • Bring challenges from your company to the table for open discussion and workable solutions to quality issues
  • Participate in a series of concurrent workshops to weigh in on topics of critical importance to the FDA and the industry.
  • Provide feedback from your company on key matters affecting the industry
  • Influence the next steps for alignment on industry and regulatory priorities

Choose from multiple education options:

  • Six comprehensive keynote presentations from FDA and pharmaceutical industry leaders
  • Four rotating workshops led by FDA and pharmaceutical industry experts so you won't miss a single topic
  • Three featured sessions on current pharmaceutical industry initiatives impacting Drug Shortage Prevention, Facilities of the Future, and Women in Pharma
  • Interactive regulatory round-table with opportunity to address questions directly with participating regulators
  • Countless opportunities for face-to-face dialogue with regulatory and pharmaceutical industry representatives who are moving pharma forward!

Detailed Agenda Expand all

Keynote and General Sessions

Opening Keynote Session
Monday, 5 June 08:30 - 10:45

General Session
Monday, 5 June 11:30 - 12:00

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

Women in Pharma
Tuesday, 6 June 07:30 - 08:15

Industry Keynote Session
Tuesday, 6 June 08:30 - 10:00

  • Roger Nosal, PhD, Vice President & Head of Global Chemistry, Manufacturing & Controls, Pfizer Inc, USA

Featured Session
Tuesday, 6 June 15:00 - 16:00

FDA Keynote Session
Wednesday, 7 June 08:30 - 10:00

  • Thomas Cosgrove, JD, Director, Office of Manufacturing Quality, FDA/CDER/OC, USA
  • Helen Saccone, PhD, Associate Director, Global Regulatory Policy, FDA/OC/OGROP, USA, Invited
  • Joseph Famulare, Vice President, Global Compliance, Genentech/Roche, USA
    Introduction and Q & A

Workshop Report-Outs
Wednesday, 7 June 10:15 - 11:10

  • George Millili, PhD, Senior Principal Technical Advisor, Genentech (A member of the Roche group), USA

Regulatory Round Table & Closing Presentation
Wednesday, 7 June 11:15 - 12:15

  • George Millili, PhD, Senior Principal Technical Advisor, Genentech (A member of the Roche group), USA
  • Rapti Madurawe, PhD, Director (Acting), Division of Process Assessment I, FDA/CDER/OPQ, USA
  • Eric Thostesen, Sr Dir. Regulatory Compliance, Johnson and Johnson, Inc., USA

Core Workshop Topics with FDA and
Pharmaceutical Industry Facilitators

Clinical Relevance Workshop

Linking Quality to Clinical Relevance (Rotation 1)
Monday, 5 June 13:00 - 14:45

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.

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, 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
  • 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 15:45 - 17:00

Linking Quality To Clinical Relevance (Rotation 3)
Tuesday, 6 June 10:45 - 12:00

Linking Quality To Clinical Relevance (Rotation 4)
Tuesday, 6 June 13:00 - 14:15

Emerging Technology & Innovation Workshop

Modernizing Pharmaceutical Manufacturing through Emerging Technology and Innovation (Rotation 1)
Monday, 5 June 13:00 - 14:45

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

Workshop Facilitators

  • Gabriella Dahlgren, PhD, Manager, Analytical Sciences & Technology, Advanced Analytics & Design To Value, Janssen Supply Group LLC, USA
  • John Lepore, PhD, Sr Dir, Chemical Engineering, Merck & Co Inc, USA
  • Frank Montgomery, PhD, Global Head, Regulatory CMC, AstraZeneca, United Kingdom
  • Mohan Sapru, PhD, Quality Assessment Lead (Acting) Office of New Drug Products, FDA/CDER/OPQ, USA

Modernizing Pharmaceutical Manufacturing through Emerging Technology and Innovation (Rotation 2)
Monday, 5 June 15:45 - 17:00

Modernizing Pharmaceutical Manufacturing through Emerging Technology and Innovation (Rotation 3)
Tuesday, 6 June 10:45 - 12:00

Modernizing Pharmaceutical Manufacturing through Emerging Technology and Innovation (Rotation 4)
Tuesday, 6 June 13:00 - 14:15

Facility & Lifecycle Quality Management Workshop

Designing Proactive Approaches to Facility and Lifecycle Quality Management (Rotation 1)
Monday, 5 June 13:00 - 14:45

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 Market Leader, BHDP Architecture, 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 15:45 - 17:00

Designing Proactive Approaches to Facility and Lifecycle Quality Management (Rotation 3)
Tuesday, 6 June 10:45 - 12:00

Designing Proactive Approaches to Facility and Lifecycle Quality Management (Rotation 4)
Tuesday, 6 June 13:00 - 14:15

Quality Metrics Workshop

Implementing Next Steps for Quality Metrics (Rotation 1)
Monday, 5 June 13:00 - 14:45

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, Johnson & Johnson Enterprise Regulatory Compliance, USA
  • Steven Greer, Corp QA External Engagement Leader, Procter & Gamble, USA
  • 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 15:45 - 17:00

Implementing Next Steps for Quality Metrics (Rotation 3)
Tuesday, 6 June 10:45 - 12:00

Implementing Next Steps for Quality Metrics (Rotation 4)
Tuesday, 6 June 13:00 - 14:15


Schedule-at-a-Glance

Monday 05 June 2017

08.30–10.45 Opening Keynote Session
10.45–11.30 Networking Break
11.30–12.00 General Education Session
12.00–13.00 Lunch
13.00–14.45 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 Industry Initiatives Presentation
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

FDA Logo
PQRI Logo

Early Registration Discount
Ends 24 April 2017! 

Keynote Speakers
Industry and FDA Leaders on the Status of Quality Manufacturing

Michael Kopcha Photograph
Michael Kopcha, PhD, RPh
Director, Office of Pharmaceutical Quality
FDA/CDER
Office of Pharmaceutical Quality Progress Update
François Sallans Photograph
François Sallans, PharmD
Vice President, Quality & Compliance, Chief Quality Officer
Johnson & Johnson
Roger Nosal Photograph
Roger Nosal, PhD
Vice President & Head of Global Chemistry, Manufacturing & Controls
Pfizer Inc.
Thomas Cosgrove Photograph
Thomas Cosgrove, JD
Director, Office of Manufacturing Quality
FDA/CDER/OC

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