Dr Robert Stephenson
Rob Stephenson Consultancy
Referent:innen
Yves Samson
Kereon
Uwe Mai
Bayer
We offer you a discount of € 600 if you book this training course together with the course "Computerised System Validation: Maintaining Compliance during Operation?". Book both courses directly as a combination here.
Zielsetzung
Systems must be qualified, and processes must be validated. These principles have applied in the pharmaceutical environment for many years. For many reasons, there are always cases in which this procedure cannot be implemented prospectively, or only with difficulty. These include equipment and systems that are purchased second-hand, equipment that has been used for non-GMP purposes, and equipment that has acquired from other companies.
Are such equipment/systems no longer fit for use in the GMP environment, or can they still be appropriately qualified and validated? This online Training course offers you solutions on how to deal with this situation and focuses on the following questions:
Are such equipment/systems no longer fit for use in the GMP environment, or can they still be appropriately qualified and validated? This online Training course offers you solutions on how to deal with this situation and focuses on the following questions:
- 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?
Zielgruppe
This online training course is aimed at subject matter experts from:
- IT
- Quality Assurance
- Production / Quality Control
- Technology
- System Suppliers and Service Providers
Technical Details
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
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
- 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?
Recording from 25 February 2025
Duration of Recording: 5h
Duration of Recording: 5h
| ECA-Member*: | € 1090,- |
| Regular Fee*: | € 1290,- |
| EU/GMP Inspectorates*: | € 645,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Computer Validation Manager"
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E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
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