Key Presentations from FDA’s Grace McNally and KarthikIyer
- Take advantage of this open forum to address how the industry is using statistics in Process Validation
- Influence the direction and industry Best Practice for use of statistics to support lifecycle approach to
- Gain greater clarity on the significant differences of opinion that still exist regarding the meaning and
intent of FDA’s statistical expectations
- Participate in interactive and open discussions on every topic!
Don’t miss these important Topics
- The Status of Implementation of the Lifecycle Approach To PV: A Regulator’s Perspective
- PPQ: Number of Batches, Acceptance Criteria Within and Between Batches, & Sampling Within a
- Using Stats to Plan Stage 3a and for Transition to Stage 3b
- Utilizing variability analysis to justify routine testing level
- Utilizing ASTM standards to justify routine testing & sampling
- Ongoing Process Capability Monitoring
- SPC and Special Cases for Process Monitoring: FDA expectations
- Implementation Options and Variability Continued Learning
- SPC methods to Monitor Process Performance
Additional Discussion Opportunities on persistent questions…
- What CQAs should have statistical acceptance criteria?
- Are there any situations where use of Statistics is Not Necessary?
- When should Baysean statistics be utilized?
- How can future performance be predicted at the end of stage 2b?
- Understand Regulatory perspectives on use of various statistical tools in various PV
- Take away efficiency gains in planning and execution of PV exercises compliant with the Lifecycle
Approach to PV expectations
- Explore advantages and disadvantages of various statistical approaches for PV stages 2
and 3, for various dosage form types and stages of manufacturing
- Improve PV stage 1 planning with a better understanding of statistical data needed to
facilitate smooth and efficient stage 2 and 3 planning
- Confirm expectations for ongoing monitoring (stages 3a and 3b) and recognize the
impact of additional variation in process input