Wolfgang Schmitt
CONCEPT HEIDELBERG
Referierende
Highlights:
· Deviation Handling
· Root Cause Analysis and Human Error
· Action Planning and Effectiveness Checks
· Root Cause Analysis and Human Error
· Action Planning and Effectiveness Checks
Zielgruppe
Personnel involved in the management, investigation and follow-up of GMP deviations and CAPA.
Zielsetzung
During this Live Online Training, you will get a thorough understanding of:
- The role of CAPA within the Pharmaceutical Quality System
- Root Cause Analysis and common investigation pitfalls
- Human Error
- Meaningful effectiveness checks
- AI opportunities and limitations
Programm
CAPA in the Pharmaceutical Quality System
- Terms and definitions:
- Regulatory expectations in EU-GMP, ICH Q9 and ICH Q10
- Step-by-step through the regulations
- Interfaces with other systems
Deviation Handling and Root Cause Analysis
- Documentation
- Immediate actions, corrections and CAPA
- Categorisation and risk assessment
- Cause, contributing causes and true root cause
- Key investigation principles
- Common pitfalls
Defining and Implementing Effective CAPAs
- When is a CAPA required – and when is it not?
- Choosing appropriate measures and checks
- Why implementation alone does not demonstrate effectiveness
- Examples
Effectiveness Checks and CAPA System Performance
- The difference between “implemented” and “effective”
- Defining SMART effectiveness criteria
- Suitable verification methods
- Useful data sources and interpreting data
- What to do when effectiveness is not demonstrated
- Examples
Human Error and Error Culture
- Why “human error” is often only the starting point of an investigation
- Learning, memory, consistency and application gaps
- Practical approaches to reduce errors
A Short Glimpse on the Use of Artificial Intelligence
- Where AI could be applied
- Boundaries
Weitere Informationen
Technical Requirements
We use Webex 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.
Fees (per delegate plus VAT)
Non-ECA Members EUR 690
ECA Members EUR 590
APIC Members EUR 640
EU GMP Inspectorates EUR 590
The conference fee is payable in advance after receipt of invoice. VAT is reclaimable.
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language
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 Manuela Luckhaupt, +49 6221 84 44-66, luckhaupt@concept-heidelberg.de
We use Webex 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.
Fees (per delegate plus VAT)
Non-ECA Members EUR 690
ECA Members EUR 590
APIC Members EUR 640
EU GMP Inspectorates EUR 590
The conference fee is payable in advance after receipt of invoice. VAT is reclaimable.
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language
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 Manuela Luckhaupt, +49 6221 84 44-66, luckhaupt@concept-heidelberg.de
Datum & Uhrzeiten
Thu, 11 Feb 2027, 09:00-12:30 h
All times mentioned are CET.
Teilnahmegebühr
| ECA-Member*: | € 590,- |
| Regular Fee*: | € 690,- |
| EU/GMP Inspectorates*: | € 590,- |
| APIC Member Discount*: | € 640,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
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E-Mail: info@concept-heidelberg.de
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