Dr Robert Stephenson
Rob Stephenson Consultancy
Referent:innen
Yves Samson
Kereon
Uwe Mai
Bayer
Highlights
- Requirements for the qualification / validation of legacy systems
- Legacy systems compliance from a QA perspective
- Data integrity for legacy systems
We offer you a discount of € 600 if you book this training course together with the course "Computerised System Validation: Maintaining Compliance during Operation" from 30 September - 02 October 2026.
Book both courses directly as a combination here.
- Requirements for the qualification / validation of legacy systems
- Legacy systems compliance from a QA perspective
- Data integrity for legacy systems
We offer you a discount of € 600 if you book this training course together with the course "Computerised System Validation: Maintaining Compliance during Operation" from 30 September - 02 October 2026.
Book both courses directly as a combination here.
Zielgruppe
- IT,
- Quality Assurance,
- Production / Quality Control,
- Technology,
- System Suppliers and Service Providers,
who have to maintain legacy systems and operate them in accordance with regulatory requirements.
Zielsetzung
- Can you still operate legacy systems, and if so, to what extent?
- What can the auditor expect, and what solutions would be considered acceptable?
- How can existing systems be specified retrospectively?
- How can compliance be achieved from a QA perspective?
- What can be done if important cybersecurity issues can no longer be technically controlled?
Programm
Query / Discussion - Problems / Expectations
- Which systems are affected?
- Why have these systems not been adequately qualified?
- Retrospective qualification
Legacy Systems regulatory Requirements and Inspections
- Old systems, legacy systems and existing non-compliant systems - characteristics and problems
- Regulatory considerations
- Annex 11 and Annex 15
- PIC/S PI 011
- GAMP GPG: The Validation of Legacy Systems
- Inspection considerations
Legacy Systems: Ensuring Compliance from a QA Perspective
- Legacy systems: IT security / virus protection / data protection
- On-site infrastructure
- System-side IT components
- Qualification / validation of legacy IT systems
How to write URS for existing Systems
- URS for existing systems: Waste of time or added value?
- Why creating URS is easier for existing systems
- Beyond the URS: the functional description
Case Studies: Contingency Planning / Support from the Manufacturer
- Initial situation for existing systems
- Manufacturer support: Hardware & software, security patches
- Mechanical spare parts
- How and what can be planned?
- What “unsolvable” dependencies exist?
What does risk-based Deployment mean for existing Systems?
- Suitability for use
- Learning from operational experience
- Importance of periodic evaluation and its results
- Quality efficiency
Old Systems, Legacy Systems and existing Systems = Data Integrity light?
- Brief overview of the ALCOA++ principles
- PIC/S PI 041-1: Data integrity
- General problems: inadequate knowledge of the pharmaceutical process and data flow, lack of data definitions, non-existent definition of the GxP relevance of the generated data
- Examples of problems with legacy systems and possible solutions
- Missing audit trail functionality vs. necessity of an operational audit trail
- Problems with user administration (no/too few users can be parameterized within the system)
- Data management: ring memory, system data on USB sticks/SD cards > how to deal with this?
Weitere Informationen
Technical Information
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 1290.-
ECA Members EUR 1090.-
APIC Members EUR 1190.-
(does not include ECA Membership)
EU GMP Inspectorates EUR 645.-
The conference fee is payable in advance after receipt of invoice.
We offer you a discount of € 600 if you book this training course together with the course "Maintaining Compliance during Operations" from 30 September - 02 October 2026 here.
ECA Members EUR 1090.-
APIC Members EUR 1190.-
(does not include ECA Membership)
EU GMP Inspectorates EUR 645.-
The conference fee is payable in advance after receipt of invoice.
We offer you a discount of € 600 if you book this training course together with the course "Maintaining Compliance during Operations" from 30 September - 02 October 2026 here.
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.
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 (Operations Director), +49 (0)6221 84 44 41, mangel@concept-heidelberg.de
Questions regarding organisation:
Ms Marion Grimm (Organisation Manager), +49 (0)6221 84 44 18, marion.grimm@concept-heidelberg.de
Datum & Uhrzeiten
Tue, 29 Sept 2026, 09.00 – 17.30 h
All times mentioned are CEST.
All times mentioned are CEST.
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
Teilnehmerstimmen
Teilnehmerstimmen - das sagen andere über unsere Seminare:
