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

5th Annual ISPE Process Validation Conference
Outcomes that Matter: Benefits of Implementing the Process Validation Lifecycle

Attend this year's conference to get presenter perspective on compl9iance, buisiness and operational efficiency lessons learned to assist participants in avoiding pitfalls and explaining the benefits of the lifecycle approach.

Highlights from this year's conference: 

  • Emphasis on application of Continued Process Verification through-out the conference
  • Design a CPV plan in small group activity for a pharmaceutical manufacturing scenario
  • Focus on adjusting data-based control strategy preparation for PPQ in interactive exercises
  • Lifecycle approach application and management for contract and generic product manufacturing
  • Application of PV lifecycle to breakthrough therapies
  • PV of Continuous Manufacturing
  • Gauge your implementation progress through audience benchmarking/pollingd

Keynote Sessions: 

Zhihou   FDA Perspective on Process Validation for Biotech Products
Zhihou, "Peter" Qiu, PhD, Branch Chief, Division of Inspectional Assessment, FDA/OPF/OPQ/CDER
     

Ranjani Prabhakara, PhD

 

Stage 3 Process validation and Quality Risk Management Procedures: ICH Q9
Ranjani Prabhakara, PhD, Team Leader, Office of Compliance, Division of Drug Quality II, FDA/CDER/OMQ

Combined Regulatory Session (for PV and PV Stats attendees)

This very popular, half a day session, overlapping the two conferences on 14 September will focus on:

  • ICH-Q12: FDA Perspective
  • Clinically Relevant Specifications - Industry Perspective
  • Industry Maturity in the Assessment and Use of Process Capapbility
  • Determining Process Capability and Determining Process Monitoring Maturity

Register Early!

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

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

Featured Speakers

Bethany Rexing Photograph
Bethany Rexing
Manager
Eli Lilly and Company
Daniel Boggs Photograph
Daniel Boggs, PhD
Engineering Consultant
Fresenius Kabi
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

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Presentations & Attendee Roster

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