Process Validation Summit 2018

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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!