Process Validation Summit 2018



Are you compliant with FDA requirements for process validation? Today’s regulators are applying more fine-grained specifications and demanding more sophisticated procedures for planning, executing, and documenting your processes throughout a drug product’s lifecycle. This two-day intensive summit brings together industry leaders to help you exceed regulatory thresholds and avoid costly FDA inspection findings.

With Representation From:

  • FDA
  • GSK
  • Pfizer
  • Abbott
  • Bayer
  • Q Pharma
  • Steris
  • PharmaTech Associates
  • Parexel
  • SynoloStats
  • Validation Edge
  • Tunnell, LLP
  • Wiley Rein, LLP
  • Compliance Team, Inc.
  • Snee Associates

Featuring Comprehensive Coverage On:

  • FDA Process Validation and Risk Management Approaches
  • Lifecycle Approach to Process Validation
  • Global Technology Transfer and Process Validation
  • Scientific and practical considerations of small scale model qualification and related statistical analyses for biopharmaceutical manufacturing processes
  • Legacy Products—From Retrospective to Prospective Process Validation
  • Validation Sampling Plans and Statistical Process Control
  • Cost-effective Process Validation Lifecycle Management
  • Implementing a Comprehensive Strategy for Process
  • Validation: Stage 3, Continued Process Verification
  • Assessing the Practical Signi cance of Statistical Study Results
  • Revalidation of Biopharmaceutical Drug Product Manufacturing Process
  • And More!
File Type

MP4, Slide Deck


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