2014 ISPE Statistician Forum
Conference Program
Conference Highlights
Exhibit Hall

The 2014 ISPE Statistician Forum was a sell-out!

Over 100 attendees had the opportunity to discuss and debate...

  • Release Testing Justification
  • Number of Batches and corresponding risk assessment 
  • PV Acceptance Criteria - Statistical Sampling; RQL/LQL vs. AQL
  • Use of Control Charts in support of process monitoring
  • Use of PPK as a reporting metric, validation and business prioritization tool
  • Specification Settings

If you missed this opportunity, please join us in June at the ISPE-FDA CGMP Conference for an update on some of this year's hottest Forum topics. 

Education Details »

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  • Why is the FDA guidance on blend uniformity being withdrawn?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.