2014 ISPE Statistician Forum

Networking Opportunities

Continue the Conversation
with the FDA, PV Experts and Fellow Statisticians!

  • Networking Reception for all Delegates, Leaders and Speakers on Monday, 31 March 2014: 17.30 - 18.30
  • Special After-Reception Discussion Session for all Delegates: Share feedback on pre-conference Discussion Papers - Monday, 31 March 2014 at 18.30
  • Discussions with FDA Interaction following each segment of the Forum
  • Networking Breaks and shared meals throughout the conference

***Bring your business cards!

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  • Why is the FDA guidance on blend uniformity being withdrawn?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

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