2014 ISPE Statistician Forum

Conference Highlights

  • Interact Directly with FDA representatives - They will participate in discussions throughout the Forum
  • Increase Your Visibility – Contribute to the output of the conference to be utilized as substrate for future sessions discussion papers, magazine/newsletter articles, and training materials
  • Engage in Open Dialogue on using statistics in Process Validation and Implementation
  • Share, Discuss, Debate and Collaborate on the future of statistical applications in this industry
  • Experienced Statisticians Only!

Education Details » Register Today »

Meet our Program Committee!

Joanne Barrick, Advisor, Global Validation, Eli Lilly & Co – Chair

Jenn Walsh, Associate Director, Manufacturing Technology, Bristol-Myers Squibb – Co-Chair

Karthik Iyer, Senior Policy Analyst, FDA/CDER/OC/OMPQ

Christopher Breen, Senior Research Scientist, Eli Lilly & Co

Jim Bergum, President, BergumSTATS, LLC

Mark Johnson, Principal Research Statistician, Abbvie Inc.

Tara Scherder, Managing Director, Arlenda Inc.

Wendy Zwolenski-Lambert, Global Validation Leader, Technical Operations, Novartis AG

Kim Vukovinsky, Senior Director, Statistics, Pfizer

Markus Kiefer, Head Manufacturing Science & Technology, Sandoz AG

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  • Why is the FDA guidance on blend uniformity being withdrawn?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