Advanced Level: Trending of Process Data for OPV/CPV - Online Training Recording

This is an advanced level course divided into three half-day parts on 15-17 October 2025.

You will learn:

• What is Ongoing/Continued Process Verification
• Overview of Control Charts of grouped and individual data
• Overview of Three-Way charts
• Overview of Attributes charts
• Stability and capability of a process
• Tools for detecting a trend and shift in process average and/or process variability
• Reasons for too many statistical false signals in real-life process data
• Ways to minimize false signals in real-life pharmaceutical and biopharmaceutical processes
• Components of a CPV/OPV plan
• Integration a practical SPC approach into the CPV/OPV plan
• Examples of control charts of real-life data of pharmaceutical processes, generated with StatGraphics, will be shown throughout the course

FDA´s Process Validation Guidance and Annex 15 to the EU GMP Guide require manufacturers to monitor product quality to ensure that a State of Control is maintained throughout the validation lifecycle of new products and legacy products during the third process validation stage called Continued Process Verification (CPV) or Ongoing Process Verification (OPV). Indeed, regulatory agencies expect manufacturers to implement also a CPV plan as reflected in FDA warning letters.

The implementation of Stage 3 is translated into establishing an ongoing CPV/OPV program which allows Identification of CPV/OPV signals and defining types of responses to these signals. However, real-life data of pharmaceutical and biopharmaceutical processes rarely meet the fundamental assumtioms of the conventional SPC (Statistical Process Control). This in turn leads often to false signal alarms, which entail futile investigations of innocuous events. Thus, a practical approach is called for and it consists of collecting, charting and evaluating product and process data under relaxed and adjusted SPC rules, allowing a streamlined implementation of the CPV/OPV program.