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

Find Solutions to Your Process Validation Challenges from Leading Regulators and Industry Experts at the 5th Annual ISPE Process Validation Conference

The 2017 ISPE Process Validation Conference will be held on 12 – 14 September 2017 in Bethesda, Maryland and will bring together industry and regulatory experts to focus on latest developments for implementing an effective process validation approach.

Benefit from technical content designed to:

  • Focus on sustaining continued evolution of a scientifically sound lifecycle approach to Process Validation
  • Define the requirements and best practices in light of regulatory expectations for the effective implementation of the lifecycle approach to Process Validation
  • Create an understanding of sources for process variability, process parameters, and their impact on product quality
  • Demonstrate the use of statistically derived sampling plans and acceptance criteria
  • Show how to maintain on-going process monitoring once the initial process validation study has been completed

Featured sessions will include topics such as:

  • Keynote: FDA Perspective on Process Validation for Biotech Products, US FDA
  • Keynote: Stage 3 PV and Quality Risk Management Procedures: ICH Q9, US FDA
  • Stage 1–2 Leveraging Data, Genentech, A Member of the Roche Group
  • ISPE Paper: Acceptance Criteria and Sampling in a Lifecycle Approach to Process Validation, AbbVie Inc.
  • Case Study: Packaging Validation Lifecycle, Bristol-Myers Squibb
  • Process Validation in the Context of Continuous Manufacturing Processes, Eli Lilly and Company
  • OPV Process and Decision Making for Large Molecule Product, Eli Lilly and Company
  • Workflows for Criticality Assessment during Process Validation Stage 1, Exputec GmbH
  • Recommended Approaches for Stage 1–3 Rollout, GSK
  • Process Validation for Accelerated and Breakthrough Programs, Merck & Co.
  • Heightened Monitoring and Testing Decisions – Application to a Post PPQ Scenario, Eli Lilly and Company

Be heard! Learn how to handle the significant challenges you face by asking questions during regulatory panels and Q&A sessions.


2 Conferences in 1 LocationISPE 2017 Process Validation Statistics Conference

Sharpen your Process Validation Statistics knowledge by taking advantage of the 2017 Process Validation Statistics Conference which happens right after the Process Validation 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, plus a half day combined regulatory session on 14 September.


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

Add to your Calendar » Register Now »


Thank you to our Program Committee!

Brad Berkowicz Photograph
Chair
Brad Berkowicz
Director
Shire
Jennifer Walsh Photograph
Jennifer Walsh
Director, Robustness & Validation
Bristol-Myers Squibb
Joanne Barrick Photograph
Joanne Barrick, RPh
Advisor, Global Validation
Eli Lilly and Co.
Gretchen Allison Photograph
Gretchen Allison
Senior Director/Team Leader
Global Quality Validation Services
Pfizer
Dominic Schiavone Photograph
Dominic Schiavone
Research Scientist
Fresenius Kabi
Maneesha Altekar Photograph
Maneesha Altekar, Phd
Principal QA Statistician
AstraZeneca
Matthew McMenamin Photograph
Matthew McMenamin
Global Validation Manager
GlaxoSmithKline
Michael Westerman Photograph
Michael Westerman
Director
Integrated Product Services
Maurice Parlane Photograph
Maurice Parlane
Principal/Director
New Wayz Consulting Ltd.

Register Early!

Register before 1 August to take advantage of the early bird rate and save!

Featured Speakers

Dr. Qiu Photograph
Zhihou "Peter" Qiu, PhD
Branch Chief
Division of Inspectional Assessment
FDA/OPF/OPQ/CDER (invited)
Ranjani Prabhakara Photograph
Ranjani Prabhakara
Team Leader
Office of Compliance, Division of Drug Quality II
FDA/CDER/OMQ (invited)
Jonathan Wade Photograph
Jonathan Wade, PhD
Research Scientist
Eli Lilly and Company
Robert IeversPhotograph
Robert Ievers
Director
Merck & Co.
Thomas Zahel Photograph
Thomas Zahel
Consultant
Exputec GmbH

Join ISPE today and save hundreds of dollars on registration as well as enjoy other great membership benefits.

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Presentations & Attendee Roster

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