Applied Statistics for FDA Process Validation

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

Future Events

Applied Statistics for FDA Process Validation 2020

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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