Process Validation 2019 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.

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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
• STERIS

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!