Dr Robert Stephenson
Rob Stephenson Consultancy
Referent:innen
Yves Samson
Kereon
Uwe Mai
Bayer
Note: All times mentioned are CET.
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 live online training 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 live online training 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 live online training is aimed at subject matter experts from:
- IT
- Quality Assurance
- Production / Quality Control
- Technology
- System Suppliers and Service Providers
Date & Technical Requirements
Date Live Online Training
Tuesday, 25 February 2025, 09.00 h – 17.30 h CET
Tuesday, 25 February 2025, 09.00 h – 17.30 h CET
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.
Programm
Gesamtes Programm als PDF herunterladen
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?
| 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
Aufzeichnung 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
Seminarprogramm als PDF
Sonderkonditionen DB BahnTeilnehmerstimmen - das sagen andere über unsere Seminare:
