2019 Process Validation Summit



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:

  • AstraZeneca
  • Bristol-Myers Squibb
  • Bausch + Lomb
  • Celgene
  • Alphora
  • Jubilant Pharma
  • VTI Life Sciences
  • Charles River Laboratories
  • Pharmatech Associates
  • SynoloStats
  • VolPal
  • Shook, Hardy & Bacon
  • Compliance Team, Inc.
  • Caliber Therapeutics
  • Beckman Coulter
  • Alcon

With Comprehensive Coverage On:

  • Introduction to Recent Advances in Process Validation – Life Cycle Approach
  • Regulations/ICH Guidance/FDA, EU perspective/PV, life cycle approaches
  • Validation in the Biopharmaceutical Industry
  • Continued Process Verification (stage 3) approaches, understanding & realization
  • Quality-by-Design, PAT, Quality Risk Management – new product vs. legacy
  • Statistical Process Control & Sampling Plans
  • Global Tech Transfers and Process Validation Approaches
  • Process Validation Biologics vs. Biosimilars, Biobetters
  • Business Perspectives on PV
  • Process Validation Biologics vs. Biosimilars, Biobetters, OTC Manufacturing
  • Enhanced Sampling in Process Performance Qualification and Continued Process Verification
  • Systematic Method for Process Development and Successful Implementation Based on Lessons Learned
  • Process Validation as the Bridge from Clinical to Commercial
  • Statistical Methods for Small-Scale Model Qualification in Bioprocessing
  • Benefits of Establishing a True End-to-End, Close to Real-time Robustness Monitoring Program
  • And Much More!


File Type

MP4, Slide Deck


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