Energy Kristina Hansen
MilCor Consulting
Referent:innen
Tim Ohlrich
gempex
Cecilie Hejlskov
Ferring
Wolfgang Schmitt
CONCEPT HEIDELBERG
Zielgruppe
- Personnel involved in failure investigations and root cause analysis (RCA)
- Quality Assurance professionals responsible for deviation management and CAPA
- Anyone contributing to or reviewing event, deviation, or CAPA management within the organisation
Zielsetzung
- Understand fundamental principles of effective failure Investigation
- Learn to distinguish true root causes from causes and symptoms such as “human error”
- Explore structured tools and methodologies
Background
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 it is possible to take the right action to solve the problem and prevent it from occurring again.
Programm
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 and 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.
Weitere Informationen
Venue
Radisson Blu Scandinavia Hotel
Amager Boulevard 70
2300 Copenhagen
Denmark
+45 33 96 50 00
guest.copenhagen@radissonblu.com
Accommodation
CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
Social Event
On 02 September you are cordially invited to a social event (including Dinner). This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
On 02 September you are cordially invited to a social event (including Dinner). This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Fees (per delegate plus VAT)
ECA Members EUR 1,890.-
APIC Members EUR 1,990.- (does not include ECA Membership)
Non-ECA Members EUR 2,090.-
EU GMP Inspectorates EUR 1,045.-
The conference fee is payable in advance after receipt of invoice and includes lunch on both days, dinner on day 1 and all refreshments. VAT is reclaimable.
Presentations/Certificate
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.
Conference language
The official conference language will be English.
The official conference language will be English.
Contacts
Questions regarding Content:
Mr Wolfgang Schmitt, +49 6221 84 44-39, w.schmitt@concept-heidelberg.de
Questions regarding organisation:
Ms Isabell Helm, +49 6221 84 44-49, helm@concept-heidelberg.de
Mr Wolfgang Schmitt, +49 6221 84 44-39, w.schmitt@concept-heidelberg.de
Questions regarding organisation:
Ms Isabell Helm, +49 6221 84 44-49, helm@concept-heidelberg.de
Datum & Uhrzeiten
Wed, 02 September 2026, 09:00–17:45
Thu, 03 September 2026, 08:30–15:30
Thu, 03 September 2026, 08:30–15:30
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
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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