Advanced Level: Trending of Process Data for OPV/CPV - Online Training Recording
A Practical Approach
Course No. 23315
Speakers
Dr Raphael Bar
BR Consulting
SPC rules in the real world for an Ongoing/Continued Process Verification Plan
Target Group
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.
Objectives
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 controlis 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.
Programme
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
Further Information
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.
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.
Conference language The official conference language will be English.
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