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!
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