Applied Statistics for FDA Process Validation

  • 05-06 Nov 2019
  • DoubleTree by Hilton Philadelphia Airport, PA, United States

Description

Applied Statistics for FDA Process Validation is a seminar that covers topics such as:

  • Appropriate sample plans based on confidence and power
  • Statistics to set specifications and validate measurement systems (assays)
  • Process Design: utilize risk management tools to identify and prioritize potential critical process parameters; and define critical process parameters and operating spaces for the commercial manufacturing process using design of experiments (DOE)
  • Suitable statistical methods into a process validation program for each of the three stages
  • Continued Process Verification: develop a control plan as part of a risk management strategy; collect and analyze product and process data; and ensure your process is in (statistical) control and capable
  • Process Qualification: assess scale effects while incorporating large (pilot and/or commercial) scale data; develop process performance qualification (PPQ) acceptance criteria by characterizing intra and inter-batch variability using process design data and batch homogeneity studies; and develop an appropriate sampling plan for PPQ

Applied Statistics for FDA Process Validation brings together attendees from:

  • Design Engineer
  • Process Scientist/Engineer
  • Regulatory/Compliance Professional
  • Product Development Engineer
  • Six Sigma Green Belt
  • Design Controls Engineer
  • Continuous Improvement Manager
  • Six Sigma Black Belt

Past Events

Important

Please, check "Applied Statistics for FDA Process Validation" official website for possible changes, before making any traveling arrangements

Event Categories

Education: Education Technologies & Methods, Training
Government & Global Issues: Law & Regulations
Health & Medicine: Medical technology, Pharma

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