Technical Process Validation Conferences Offer Implementation Solutions for All Three Stages of the Product Lifecycle

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ISPE will host its 2017 Process Validation and Process Validation Statistics Conferences in Bethesda, Maryland, 12 – 15 September. These concurrent events offer comprehensive solutions to process validation lifecycle challenges faced by process validation professionals and statisticians today.

“These conferences are invaluable due to the breadth of process validation lifecycle challenges addressed and the opportunity to interact with experienced and leading practitioners and regulatory experts,” said John Bournas, ISPE CEO and President.

Designed to expand attendee knowledge of the many facets of process validation, these back-to-back events cover the entire Process Validation Lifecycle - from Stage 1 Process Design through Stage 3 Continued Process Verification (CPV). Benchmarking opportunities abound through shared real-world experiences of successes and challenges from presenters and fellow professionals.

Process Validation Conference | 12 – 14 September

  • Keynotes:
    • Zhihou "Peter" Qui, PhD, Branch Chief, Division of Inspectional Assessment, FDA/OPF/OPQ/CDER
    • Ranjani Prabhakara, PhD, Team Leader, Office of Compliance, Division of Drug Quality II, FDA/CDER/OMQ
  • Featured FDA Sessions:
    • FDA Perspective on Process Validation for Biotech Products
    • Stage 3 Process Validation and Quality Risk Management Procedures: ICH Q9

Process Validation Statistics Conference | 13 – 15 September

  • Keynote:
    • Kit Roes, PhD, Professor of Clinical Trial Methodology, University Medical
    • Center Utrecht and Observer in the EMA Biostatistics Working Party
  • Featured FDA Sessions:
    • Application of Statistics in the Process Validation Lifecyle
    • Considerations for Continuous Manufacturing Implementation throughout a Product Lifecycle: FDA Perspective

Attendees of both conferences will have access to two concurrent evening sessions, a half day regulatory session, a networking reception, and a registration discount.

Learn more and register today for the Process Validation and Process Validation Statistics Conferences.

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