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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Why is the FDA guidance on blend uniformity being withdrawn?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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