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

Find out how you can use statistics in support of the lifecycle approach to process validation at the 4th Annual ISPE Process Validation Statistics Conference

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

Featured Sessions:

  • Analytical Quality by Design (AQbD) in Pharmaceutical Development, Pfizer Inc.
  • A PV-1 Statistical Approach to Aid Process Parameter Criticality Assignment, Pfizer Inc.
  • End-to-End Risk Assessment Strategy for Multi-Stage Processes in the Process Validation Lifecycle: Applying Statistical Approaches Commensurate with Business Risks, Bristol-Myers Squibb
  • PPQ Sampling Plans and Bayesian Tolerance Intervals Using R-Shiny, Janssen Pharmaceuticals
  • Statistician’s Perspective on Contract Manufacturing, Shire

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.

Add to your Calendar » Register Now »


Thank you to our Program Committee!

Tara Scherder Photograph
Co-Chair
Tara Scherder
Partner, SynoloStats
Lori Pfahler Photograph
Co-Chair
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
AstraZeneca
James Bergum Photograph
James Bergum
Statistical Consultant
Bergumstats
Mark Johnson Photograph
Mark Johnson
Senior Manager
AbbVie
Daniel Peng  Photograph
Daniel Peng
Shire
Kimberly Vukovinsky Photograph
Kimberly Vukovinsky
Senior Director
Nonclinical Statistics
Pfizer

Register Early!

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

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
FDA/OPQ/CDER
Arwa El Hagrasy, PhD Photograph
Arwa El Hagrasy, PhD
Acting Quality Assessment Lead
FDA/OPF/CDER
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: