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
- 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!
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