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Process Validation Summit 2017

$395.00

Category:

Are you compliant with FDA requirements for process validation? 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
  • Abbott
  • Bayer
  • Genzyme
  • GSK
  • QPharma
  • Patheon
  • Pfizer
  • Arlenda
  • Snee Associates
  • PharmaTech Associates
  • Compliance Team Inc
  • ResMedica
  • Stat4Ward
  • Takeda
  • BergumSTATS
  • TARIS Biomedical
  • Tunnell Consult

Featuring Comprehensive Coverage On:

  • FDA Process Validation and Risk Management Approaches
  • Lifecycle Approach to Process Validation
  • Global Technology Transfer and Process Validation
  • Achieving the Business and Compliance Benefits of Quality by Design (QbD) and Continued Process Verification (CPV)
  • 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
  • Establishing a Continuum of Criticality for Process Parameters and Quality Attributes Throughout the Lifecycle
  • Process Control Strategy and Process Performance Qualification of a Drug/Device Combination Product
  • The Drug Supply Chain Security Act-How Does it Relate to Validation?
  • And Much More!