Dr Raphael Bar
BR Consulting
Referierende
SPC rules in the real world for an Ongoing/Continued Process Verification Plan
Zielgruppe
This is an advanced level online training 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
You will learn:
- What is Ongoing/Continued Process Verification?
- What is variability of data?
- 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 assumtions 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"
Variability of Data
- Standard deviation of a sample and of population
- Histogram
- Standard deviations of the mean Range
- Relation between standard deviation and Range
- Short-term variation versus global Variation
- Separating the signal from noise
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 a recording, 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 recording, you can decide on what date you want to watch the training course online. Starting from the access date you entered during the registration process, the stream will be available to you for 7 days. Within this timeframe, you can start and 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: Recordings do 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.
Timing and Duration:
When you register for the recording, you can decide on what date you want to watch the training course online. Starting from the access date you entered during the registration process, the stream will be available to you for 7 days. Within this timeframe, you can start and 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: Recordings do 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.
Fees (per delegate plus VAT)
ECA Members EUR 1,590
ECA Members EUR 1,690
Non-ECA Members EUR 1,790
EU GMP Inspectorates EUR 895
The conference fee is payable in advance after receipt of invoice.
ECA Members EUR 1,590
ECA Members EUR 1,690
Non-ECA Members EUR 1,790
EU GMP Inspectorates EUR 895
The conference fee is payable in advance after receipt of invoice.
Conference language
The official conference language will be English.
Contacts:
Questions regarding content:
Mr Sven Pommeranz, +49 6221 84 44-47, pommeranz@concept-heidelberg.de
Questions regarding organisation:
Mr Ronny Strohwald, +49 6221 84 44-51, strohwald@concept-heidelberg.de
Recording from 14-16 October 2026
Duration of the recording: 5h 54m
Duration of the recording: 5h 54m
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
Weitere Termine vor Ort
Weitere Termine vor Ort 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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