Advanced Level: Trending of Process Data for OPV/CPV - Live Online Training
15-17 October 2025
Course No. 21995
Speakers
Dr. Raphael Bar
BR Consulting
All times mentioned are CEST.
Objectives
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
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. 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.
Date & Technical Requirements
Date of the Live Online Training 15 October 2025, 09.00 – 12.00 h 16 October 2025, 09.00 – 13.00 h 17 October 2025, 09.00 - 13.00 h All times mentioned are CEST
Technical Requirements We use Webex Events for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Examples: control charts of Assay, impurity, of UOC, dissolution
Overview of Control Charts of Attributes
Their use in the pharmaceutical industry
Np and p control charts
c and u control Charts
Examples: control Np charts of inspected packages (defective), c charts of non-conformities (defects) in labels of a drug product; c chart of environmental microbial counts
Detecting Drifts and Trends
Pattern and Trends in Data
Moving Averages
Nelson Rules
Detecting small shifts
Simple Cusum Charts
October 17, 09:00 – 13:00h
Evaluation of a Control Chart
Nelson rules for detecting trends and shifts
"State of Control" versus "State of Statistical Control"
Phase I and Phase II in control charting
"Statistical Limits" versus "Regulatory Limits"
Are all statistical assumptions valid in real-world pharmaceutical process data?
Adjusting SPC Rules to Pharmaceutical Process Data
Which statistical rules can be relaxed
Setting practical limits
Examples of process behaviour charts
Components of a CPV/OPV Plan
Identification of CPV Signals
Types of responses to Signals
Structure of OPV/CPV Plan
Basic components of an OPV/CPV Plan
Set of SOPs
Identification of OPV/CPV signals
What level of monitoring?
Types of responses to OPV/CPV signals
Roadmap of OPV/CPV Plan
Policy of OPV/CPV Implementation
Recommendations for a GMP-compliant implementation
Artificial Intelligence in OPV/CPV
This course is part of the GMP Certification Programme "ECA Certified Validation Manager" Learn more
Testimonials
Seminar Programme as PDF