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

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

Attend this year's conference to get presenter perspective on compliance, business 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/polling

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

 2 Conferences, 1 Location

ISPE 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 » View Education » 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.

 

Save an additional 25%!

 Register for 
Process Validation and Process Validation Statistics Conference 

Featured Speakers

Bethany Rexing Photograph
Bethany Rexing
Manager, Technical Services/ Manufacturing Science
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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