Eberhard Kwiatkowski
PharmAdvantageIT
Referierende
Stefan Münch
Körber Pharma Consulting
Yves Samson
Kereon
Does CSA lead to changes during the validation of computerised systems? - Opportunities and limitations in the pharmaceutical industry.
Zielgruppe
Staff from the Life Sciences Business (pharmaceuticals / medical devices / suppliers / consultancy) in the following areas:
- IT
- Quality Assurance
- Manufacturing
- Quality Control
Zielsetzung
Why should you attend this event?
- The background to the FDA’s CSA (Computer Software Assurance) initiative will be presented
- Does CSA replace CSV? You will learn about the connections and differences between CSV (Computerised System Validation) and CSA
- What benefits does CSA offer for software validation?
CSA is the result of an initiative by the life sciences industry and the FDA to promote a risk-based approach that focuses more strongly on software quality while significantly reducing the documentation burden. Following an initial draft in 2022, the FDA published the final version on 3 February 2026.
Programm
Background / Application to Medical Devices / Applicable to Pharmaceuticals?
- Medical devices vs pharmaceutical GxP
- European Union
- USA
- 2017–2026: CSA development. From the triggers to the final version (February 2026)
- Differences in context between medical devices and pharmaceutical applications and devices
CSA Risk Framework
Identifying the Intended Use
- When is validation necessary?
- Risk-based scaling
- Procedure for using the cloud
Determining the Risk-Based Approach
- Risk-based approach according to ISO 13485
- Comparison with ISO 14971
- Identification of risks in software applications
- Binary or spectrum – which is it?
Production of Quality System Software Changes
- How much validation evidence is needed?
- Defined user requirements
- Validation of off-the-shelf software and automated equipment
- Validated according to a written procedure for the particular intended use
Determining the Appropriate Activities
- From specifications to testing
- 50 shades of testing
Additional Considerations for Assurance Activities
- Activities and established processes that provide control in production
- Additional process controls, including activities to reduce cybersecurity exposure
- The data and information collected periodically or continuously by the software
- The use of tools supporting software development and system life cycle activities
- The use of testing and results carried out in iterative cycles
Establishing the Appropriate Records
- How much quality assurance documentation is required?
- Effective use of digital resources
Considerations for Electronic Records Requirements
- When does 21 CFR Part 11 apply?
- Which records are affected under 21 CFR Part 820?
- How do I explain this to the regulatory authority?
Examples:
Example 1: Nonconformance Management System
- Standard (off-the-shelf) systems and the effective use of supplier involvement
- What is expected / what should be done?
Example 2: Learning Management System (LMS)
- Learning Management System (LMS) applying a risk-based approach
- Established SOP for evaluating suppliers
- Developing a risk-based assurance strategy
CSV vs. CSA – Relationship to other Regulations
- Clarification of terms
- CSV vs. CSA – Key differences
- Relationship to other regulations (ISO standard environment)
Assessment – What is Good, Useful, Unsuitable
- Critical thinking: The CSA’s ‘poltergeist’
- Optimising compliance activities
- Focus on what is truly relevant and necessary
- A computer-based system is not the same as computer software
- What about quality control equipment and production facilities?
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)
ECA Members EUR 1,090
APIC Members EUR 1,190
Non-ECA Members EUR 1,290
EU GMP Inspectorates EUR 645
The conference fee is payable in advance after receipt of invoice.
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.
APIC Members EUR 1,190
Non-ECA Members EUR 1,290
EU GMP Inspectorates EUR 645
The conference fee is payable in advance after receipt of invoice.
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:
Dr Andreas Mangel, +49 6221 84 44-41, mangel@concept-heidelberg.de
Questions regarding Organisation:
Mr Rouwen Schopka, +49 6221 84 44-13, schopka@concept-heidelberg.de
Datum & Uhrzeiten
Wed, 10 Feb 2027, 09:00 -17:00 h
All times mentioned are CET.
Teilnahmegebühr
| ECA-Member*: | € 1090,- |
| Regular Fee*: | € 1290,- |
| EU/GMP Inspectorates*: | € 645,- |
| APIC Member Discount*: | € 1190,- |
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 Computer Validation Manager"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
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