Statistical Approaches for Improving Performance and Compliance
Use of statistics has been part of the FDAâ€™s guidances and regulations for many years. Use of statistics is an integral part of the Jan 2011 FDA Process Validation Guidance. It can be argued that the FDA is looking for the pharma and biotech industries to make even greater use of statistical thinking and methods. Are you compliant with FDA requirements? Todayâ€™s regulators are applying more fine-grained specifications and demanding more sophisticated procedures for planning, executing, and documenting your processes throughout a drug productâ€™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:
- Eli Lilly
- Snee Associates LLC
- JnJ Vision Care
- Upsher-Smith Laboratories
- Insight, Advice and Solutions, LLC
- Excellent Pharma Consulting
- Catalent Biologics
With Comprehensive Coverage On:
- Solving Statistical Mysteries â€“ What Does the FDA Want?
- Stability and Capability of Measurement System and Manufacturing Process is Fundamental to Pharmaceutical Quality Assurance in the 21st Century
- Strategies forAccelerating Process and Formulation Validation
- Measurement Systems Analysis and Some Useful Experimental Designs
- Continued Process Verification and Fit for Use Statistical Approaches
- The Need for both Fundamental and Advanced Understanding to Design Lean Statistical Approaches
- Test Method Robustness/Design Space
- And Much More!