Advanced Level: Trending of Process Data for OPV/CPV - Live Online Training
8/9 October 2024
Course No. 21353
Speakers
Dr. Raphael Bar
BR Consulting
All times mentioned are CEST.
Objectives
This is an advanced level course divided into two parts.
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
Background
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.
Target Group
This is an advanced level course, therefore a knowledge on control charts is an advantage. Experienced employees from companies, who are involved in pharmaceutical process validation activities (developers, QM, manufacturing, heads of validation departments, etc.) especially regarding stage 3 ongoing/continued process verification, are addressed. Of course consultants in this field, who want to get information from the view of the medicinal product manufacturers, are addressed too.
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Seminar Programme as PDF