2014 ISPE Statistician Forum

Conference Program

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 and Implementation
  • Influence the direction and industry Best Practice for use of statistics to support lifecycle approach to Process Validation
  • 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 Batch
  • 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 stages
  • 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

Conference Handouts

Handouts Now Available »

Attendee Roster Now Available » locked to attendees only

Explore Answers to These Questions!

  • Are you applying the right statistical approaches to Process Validation? What misapplications of statistics have been observed by FDA?
  • Why is the FDA guidance on blend uniformity being withdrawn? What is your opinion regarding impact to current and future product development efforts?
  • How will you handle tightened expectations regarding USP or ICH UDU criteria?
  • Do you know if the expectations are similar with regard to statistical sampling and acceptance criteria for small and large molecule products?
  • When does a validation fail? What level of confidence /coverage/ acceptance criteria must be met to continue to make and release batches?
  • What historical data such as CQA variability should drive decisions regarding revalidation?
  • Are you using best practices for applying risk assessment, science, variability and statistics to determine the number of PPQ batches?
  • Do you know the role of input variability in determining readiness for PV?
  • When do you think it is appropriate to apply statistical methods to process input parameters?
  • Should you apply statistical justification of routine sampling and testing to all dosage forms and API?
  • What statistical signals would you utilize to determine the need for remediation?
  • In addition to Critical Quality Attributes, are there other areas of the process appropriate you should use for monitoring statistical methods? Which statistical methods are appropriate?

Indicates content available to ISPE members only.