Dr. Raphael Bar
BR Consulting
Referent:innen
Zielgruppe
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.
Zielsetzung
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.
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.
Programm
Introduction
- What is Ongoing/Continued Process Verification?
- Regulations
- What data to trend
- Process inputs and outputs: CPP and CQA
- NOR, PAR and Design Space
- Run Chart versus Control Chart
- Common cause variation versus special variation
- "State of Control"
Overview of Control Charts of Variables I
- Overview of Control Charts of grouped data
- Overview of Control Charts of individual data
- Overview of Three-Way Charts
Overview of Control Charts of Variables II
- Capability indices (Cp, Cpk, Pp and Pk)
- Stability and capability of a process
- 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
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
Weitere Informationen
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Contacts
Questions regarding content:
Mr Sven Pommeranz, +49 (0)6221 84 44 47, pommeranz@concept-heidelberg.de
Questions regarding organisation:
Mr Ronny Strohwald, +49 (0)6221 84 44 51, strohwald@concept-heidelberg.de
Recording from 15-17 October 2025
Duration of Recording: 8 hours 40 min
Teilnahmegebühr
| ECA-Member*: | € 1590,- |
| Regular Fee*: | € 1790,- |
| EU/GMP Inspectorates*: | € 895,- |
| APIC Member Discount*: | € 1690,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Validation Manager"
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E-Mail: info@concept-heidelberg.de
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