Ongoing/Continued Process Verification - Live Online Training
22/23 May 2024
Course No. 21204
Speakers
Dr Line Lundsberg-Nielsen
NNE
Dr Chris Watts
VoPal
Dr. Thomas Schneppe
Dr. Rainer Gnibl
GMP Inspektor, Regierung von Oberbayern
Dr Ingolf Stückrath
Sanofi-Aventis Deutschland
Sarah Zimmet
Boehringer Ingelheim
All times mentioned are CEST.
Objectives
With the Guidance for Industry “Process Validation: General Principles and Practices”, the FDA requires a new direction. Validation is now a „Life Cycle Process” with 3 stages:
Process Design
Process Qualification
Continued Process Verification
The stage 3 “Continued Process Verification” is a new step in validation. Also legacy process should be (re)validated regarding this life cycle. The start is stage 3 “Continued Process Verification”. The goal of the third validation stage is continual assurance that the process remains in a state of control (the validated state) during commercial manufacture. A system or systems for detecting unplanned departures from the process as designed is essential to accomplish this goal, says the Guidance. Now, also the EU requires Ongoing Process Verification as part of a Validation Life Cycle.
But how to implement Continued/Ongoing Process Verification in the routine production – beginning from the definition of the Control Strategy to the Product Quality Review / Annual Product Review?
What is state of the art regarding systems for detecting unplanned departures from the process?
How to handle the monitoring at Stage 3 (Continued/Ongoing Process Verification)?
What are the differences between Continued Process Verification (FDA), Continuous Process Verification
(ICH Q8) and Ongoing Process Verification (EU)?
Are there parallels regarding Medical Devices?
What statistic parameters could help?
Is a statistician necessary?
How is OPV/CPV linked to PQR/APR?
What are the expectations of an EU Inspector?
These questions are discussed, and the possibilities for implementation are covered.
Background
Since 1987 the FDA Guideline on Process Validation has been the basis for qualification and validation. A new FDA Policy Guide of 2004 gives some hints as to the new validation approach. In January 2011 the new “Guidance for Industry Process Validation: General Principles and Practices” was published as final guidance. That is now FDA’s „current thinking“. EMA’s new Process Validation Guidance also mentions a Life Cycle Approach for Process Validation. And with the citation of ICH Q8, the possibility to do Continuous Process Verification is also mentioned. In the Annex 15 revision document, valid since 1 October 2015, also a Continued Process Verification, called Ongoing Process Verification, is now a requirement.
Target Group
The addressees of the event are qualified staff charged with or responsible for validation activities, especially regarding stage 3 (Continued/Ongoing Process Verification) of the Process Validation Life Cycle. We mean commissioners for validation, heads of quality assurance, department heads, etc. It also addresses members of validation teams (e.g. chemists, pharmacists, microbiologists) as well as staff who is involved in process monitoring activities and Consultants.
Technical Requirements
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Seminar Programme as PDF