2012 Process Validation, 17 - 18 October, Silver Spring, MD

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New expectations are bringing about significant changes in Process Validation approaches. As a result, companies are struggling to understand how these expectations can be transformed into practical actions and business processes.

ISPE is offering this interactive, topic-specific Conference on how to implement these changes into your business, gain clarity and be compliant with the FDA Process Validation Guidance.

Subject Matter experts will offer insight around the Guide and suggest practical approaches to satisfying these requirements. A question and answer session will follow, offering an opportunity for you to gain clarity around the Guide.

Through small group exercises and discussion forums, you will be able to practice application of the lifecycle approach and discuss approaches from your colleagues. These exercises will focus on acceptance criteria, sampling plans, determining batches and the elements of a heightened monitoring plan. Larger group sessions will provide additional opportunity for benchmarking approaches.


  • Joanne Barrick, Advisor, Global Validation Support, Eli Lilly & Co., USA


  • Dave Dolgin, Sr. Quality Program Manager, Abbott Laboratories, USA
  • Kurtis Epp (Invited), Senior Manager, Manufacturing, BioTechLogic, USA
  • Joe Famulare, Sr. Director, Genetech, USA
  • Jeff Flemming, Pfizer, Inc., USA
  • Karthik Iyer, Senior Policy Advisor, FDA, USA
  • John Lepore, Sr. Director-Chemical Process Development and Commercialization, Merck, Inc., USA
  • Catherine McHugh (Invited), Irish Medicines Board
  • Grace McNally, Consumer Safety Officer, FDA, USA
  • Anne Renton, Quality Consultant, Eli Lilly & Co., USA
  • Mark Varney, Sr. Quality Consultant, Abbott Laboratories, USA