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