Advanced Level: Trending of Process Data for OPV/CPV - Live Online Training

8/9 October 2024

Course No. 21353

header-image

Speakers

Dr. Raphael Bar

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.

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.

Programme

Advanced Level: Trending of Process Data for OPV/CPV - Live Online Training

Seminar Programme as PDF

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
  • Overview of Control Charts of grouped data
  • Overview of Control Charts of individual data
  • Overview of Three-Way charts
  • 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
  • xamples: 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
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

stop

This course is part of the GMP Certification Programme "ECA Certified Validation Manager" Learn more

This training/webinar cannot be booked. Send us your inquiry by using the following contact form.

To find alternative dates for this training/webinar or similar events please see the complete list of all events.

For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.

* also payable by credit card
American Express Visa Mastercard

icon
Further dates on-site
Further dates on-site
Not available
icon
Further dates online
Further dates online
Not available
icon
Recording
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

Woman with headset

Go back

Testimonials about our courses and conferences

"Great material and speakers" and "Great speakers a lot of experience and sharing"

Felipe Gonzalez, Mucos Emulsionsgesellschaft mbH
Live Online Training - Granulation & Tableting, September 2024

"Very good balance between general and detailed information"

Dr Ralf Albrecht, Tillotts Pharma AG
Live Online Training - Granulation & Tableting
September 2024

"Nice presentations: easy understanding, quite visual"

Susana Manrique, Boehringer Ingelheim España, S.A,
Live Online Training - Granulation & Tableting, September 2024

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023

 

“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024

 

“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024

 

 

“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023