CAPA: Principles and Practical Implementation - Live Online Training
Step-by-step from Deviation Documentation to Effective CAPA Closure
Thursday, 11 February 2027 9 .00 - 12.30 h
Course No. 23180
Speakers
Wolfgang Schmitt
CONCEPT HEIDELBERG
Highlights:
· Deviation Handling · Root Cause Analysis and Human Error · Action Planning and Effectiveness Checks
Target Group
Personnel involved in the management, investigation and follow-up of GMP deviations and CAPA.
Objectives
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
Programme
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
Further Information
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.
Testimonials
