Applied Statistics for FDA Process Validation

Topics

• 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

Who should Attend

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