Energy Kristina Hansen
MilCor Consulting
Referent:innen
Tim Ohlrich
gempex
Cecilie Hejlskov
Ferring
Wolfgang Schmitt
CONCEPT HEIDELBERG
Zielsetzung
During this course, you will get to know the principles and discuss all relevant aspects to perform failure investigations to get to the true Root Cause of a problem. This is the key for efficient Event Management and CAPA Systems.
Hintergrund
Things will go wrong from time to time. In the world of pharmaceuticals, we need to ensure that we have robust processes and procedures in place to deal with such situations. When an unplanned event arises, it must be handled accordingly.
EudraLex Vol. 4, EU-GMP Guidelines,
Chapter 1 (Pharmaceutical Quality System):
1.4 (xiv): “An appropriate level of root cause analysis should be applied during the investigation of deviations, suspected product defects and other problems.”
In any case a sound failure investigation is the key to identify appropriate actions and CAPAs. Here, understanding how to handle both human error- and non-human error-based non-conformances is crucial.
EudraLex Vol. 4, EU-GMP Guidelines,
Chapter 1 (Pharmaceutical Quality System):
1.8: […] “The basic requirements of GMP are that: (vii) Any significant deviations are fully recorded, investigated with the objective of determining the root cause and appropriate corrective and preventive action implemented”
Root cause analysis (RCA) is a process that attempts to identify the exact cause of a problem, such as a deviation. Only by identifying the exact underlying fault is it possible to take the right action to solve the problem and prevent it from occurring again.
Zielgruppe
This course is designed for all personnel involved in failure investigation/Root Cause Analysis concerning events, deviations and CAPA activities in their company. It is addressed to persons from Quality Assurance and Control, Manufacturing and R&D.
Date / Venue / Presentations / Certificate
Date
Tuesday, 28 October 2025, 09.00 – 17.45 h
(Registration and coffee 08.30 – 09.00 h)
Wednesday, 29 October 2025, 08.30 – 15.30 h
Venue
Barceló Hotel Hamburg
Ferdinandstraße 15
20095 Hamburg, Germany
Phone +49 (0) 40/22 63 62 0
Email hamburg.res@barcelo.com
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.
After the event, you will automatically receive your certificate of participation.
After the event, you will automatically receive your certificate of participation.
Programm
Gesamtes Programm als PDF herunterladen
Kick-off: When it’s human
- Expectations on Humans
- Why human error could not be a root cause
- Blame culture vs. Root Cause
- Error Culture
Excerpt from FDA Warning Letter
“…the investigation failed to establish a root cause and your quality unit failed to ensure the implementation of adequate corrective actions to prevent future recurrence.”
Presentation and Workshop:
Using 5 Whys und Ishikawa
- Short Introduction of the methods
- Strengths and weaknesses of each method
- Typical mistakes in application
- Workshop: Real life examples and experiences
Interactive Session: Comparative Analysis
- Identifying and documenting errors with worksheets
- The need for a systematic approach
- The key for success: comparison of occurred deviations with available facts
Bow-Tie Risk Management and Problem Solving Analysis
- Controls, connection and causality
- Risk velocity
- Preventive- detective and corrective controls
- The link to Fault Tree Analysis and Event Tree Analysis
Interactive Session: A3 Methodology
- What is a problem?
- The causes investigation; point of cause, direct cause and root cause
- The 8-steps, structure and methodology
- Deep Dive: Point of cause analysis
- Solving a murder case
Human Error Related Deviations
- The What
- Top 10 Categories: FDA Warning letters (2021 -2022)
- The commonality
- Undesirable behaviour…what is it? - The How
- The KAP model
- Factor in the social element - The Recurrence
- Human Error is NEVER a root cause
- Blame it on the culture
Behavioural Root Cause Analysis (bRCA) for Human Error Related Deviations (HErD)
- Behavioural Root Cause Analysis tool (3B Method)
- Theory behind 3B method
- Informative construct (brain) - - Motivational construct (beating heart)
- Perceived barriers construct (brick) - Utilize the solution
- Sort the HErD - 3B Method
- Practice in groups
RCA Completion
- How to document a Root Cause Analysis
- How to define the right actions based on the outcome
Deviation Management and CAPA
Principles and all relevant aspects to implement, improve and/ or work with a Deviation Management and CAPA System are topic of ECA’s Deviation Management and CAPA training course. For more information see www.gmp-compliance.org/ or send an e-mail to w.schmitt@concept-heidelberg.de.
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This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager"
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E-Mail: info@concept-heidelberg.de
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