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

5th Annual ISPE Process Validation Conference is the answer to your process validation questions!

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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.

Highlights from this year's conference: 

  • Emphasis on application of Continued Process Verification, recently noted by FDA as the greatest remaining PV lifecycle implementation challenge
  • Small group activity where participants will work together to practice designing a CPV plan for a pharmaceutical manufacturing scenario
  • Interactive exercise focusing on adjusting a control strategy based on data in preparation for PPQ.
  • Other presentation topics will include:
    • Lifecycle approach application and management for contract and generic product manufacturing
    • Application of PV lifecycle to breakthrough therapies
    • PV of Continuous Manufacturing
  • Electronic polling sessions through out the conference will capture audience benchmarking survey results allowing participants to gauge their implementation progress.
  • Additionally, presenter perspective on compliance, business and operational efficiency lessons learned to assist participants in avoiding pitfalls and explaining the benefits of the lifecycle approach, will be presented

Hear regulatory perspectives from FDA speakers: 

  • FDA Perspective on Process Validation for Biotech Products by Zhihou, "Peter" Qiu, PhD, Branch Chief, Division of Inspectional Assessment, FDA/OPF/OPQ/CDER. Dr. Qiu will discuss common process validation challenges encountered during Biologics License Applications (BLA) reviews and inspections. He will also review unique regulatory requirements for validating biotech products suggest areas of emphasis and areas for improvement.
  • Stage 3 Process Validation and Quality Risk Management Procedures: ICH Q9 by Ranjani Prabhakara, PhD, Team Leader, Office of Compliance, Division of Drug Quality II, FDA/CDER/OMQ. Dr. Prabhakara will present her perspective about the use of risk-based tools and assessment in designing a meaningful PV Stage 3 monitoring plan.

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.

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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!

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

Featured Speakers

Dr. Qiu Photograph
Zhihou "Peter" Qiu, PhD
Branch Chief
Division of Inspectional Assessment
FDA/OPF/OPQ/CDER
Ranjani Prabhakara Photograph
Ranjani Prabhakara, PhD
Team Leader
Office of Compliance, Division of Drug Quality II
FDA/CDER/OMQ
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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