Process Validation Statistics Conference, 12-14 September 2017, Bethesda Marriot, Bethesda, MD

4th Annual ISPE Process Validation Statistics Conference is your answer to using statistics in support of the lifecycle approach to process validation

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Join fellow statisticians at ISPE 2017 Process Validation Statistics Conference, 13 - 15 September 2017 in Bethesda, Maryland, where for the past four years, statisticians, like you, come together and experience:

  • Comprehensive forum for statisticians and those skilled in the use of statistics, to explore the merits and challenges of existing and new statistical approaches
  • State-of-the-art approaches to implementing statistical elements that support the lifecycle approach to Process Validation
  • Exceptional opportunity to experience current best practices in the use of statistics for lifecycle process validation, reflect on past practices, examine current trends, and explore future challenges

Keynote Session: 

"The EMA (Draft) Reflection Paper on Statistical Methodology for the Comparative Assessment of Quality Attributes" will be presented by Professor Kit Roes. Dr. Roes is Professor of Clinical Trial Methodology at the Julius Center of the University Medical Center Utrecht and is chair of the Working Group Methodology of the Dutch Medicines Evaluation Board and observer in the EMA Biostatistics Working Party.
He leads the methodology group as part of the UMC Utrecht Trial Innovation ALiance. His present research focus is on design and analysis of clinical trials, with an emphasis of innovative designs and bridging the gap between clinical trials and real world evidence. He participates in the Regulatory Science Network Netherlands and is Principal Investigator of the EU Framework Program 7 project Asterix, on design and analysis of clinical trials for drug development in rare diseases. 

Featured FDA Sessions:

  • Application of Statistics in the Process Validation Lifecyle by Milva Melendez, Senior Consumer Safety Officer, Inspection Assessment Branch, Office of Surveillance, FDA/OPQ/CDER. Ms. Melendez will provide her perspective on enhancing the use of statistics in process validation. She will give status update of statistical training provided to FDA inspectors and signals related to PV and process variability and robustness
  • Considerations for Continuous Manufacturing Implementation throughout a Product Lifecycle: FDA Perspective by Arwa El Hagrasy, PhD, Acting Quality Assessment Lead, FDA/OPF/CDER. Dr. Hagrasy will present an overview of process development and control strategy considerations for continuous pharmaceutical manufacturing and role of the pharmaceutical quality system throughout the product lifecycle. Attendees will also gain regulatory perspective in leveraging process information in decision making and continuous process improvement.

ISPE 2017 Process Validation Conference2 Conferences in 1 Location

Sharpen your Process Validation knowledge by taking advantage of the 2017 Process Validation Conference which happens right before the Process Validation Statistics Conference.  Plus by registering for both conferences, we'll give you 25% off!

Attendees who register for both conferences will have access to a networking reception and two concurrent sessions in the evening on 13 September; Statistics for Beginners and a Statistics Forum, and a half-day combined regulatory session on 14 September.

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Thank you to our Program Committee!

Tara Scherder Photograph
Tara Scherder
Partner, SynoloStats
Lori Pfahler Photograph
Lori Pfahler
Executive Director, Merck
Joanne Barrick Photograph
Joanne Barrick
Advisor Global Validation Support
Eli Lilly and Company
Jennifer Walsh Photograph
Jennifer Walsh
Director Robustness & Validation
Bristol-Myers Squibb
Maneesha Altekar Photograph
Maneesha Altekar
Principal QA Statistician
James Bergum Photograph
James Bergum
Statistical Consultant
Mark Johnson Photograph
Mark Johnson
Senior Manager
Daniel Peng  Photograph
Daniel Peng
Kimberly Vukovinsky Photograph
Kimberly Vukovinsky
Senior Director
Nonclinical Statistics

Register Early!

Register before 1 August to take advantage of the early registration rates and save! 

Get an additional 25% discount when you register for both Process Validation Statistics and Process Validation Conference, taking place right before!

Don't Miss a Single Session
Get the most of your conference experience by passing this along to your statistician colleagues and take advantage of group discounts.

Featured Speakers

Milva Melendez Photograph
Milva Melendez
Senior Consumer Safety Officer
Inspection Assessment Branch
Office of Surveillance
Arwa El Hagrasy, PhD Photograph
Arwa El Hagrasy, PhD
Acting Quality Assessment Lead
Brent Harrington Photograph
Brent Harrington
Associate Director – Statistics Group
Pfizer Inc.
Dave Enck Photograph
Dave Enck
Director for Design to Value and QE
Janssen Pharmaceuticals
James Crichton Photograph
James Crichton
Principal Statistician
Cook Pharmica

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Presentations & Attendee Roster

Conference Attendees: