Dr. Rainer Gnibl
GMP Inspektor, Regierung von Oberbayern
Referent:innen
Yves Samson
Kereon
Dr Bernhard Appel
Roche
Please note: All times mentioned are CET.
Zielsetzung
GMP-relevant computerised systems must be validated. The validation activities shall be sufficiently documented in order to allow inspectors as well as internal and external auditors to review and to understand the validation rigour and accuracy. The live online training will give an overview of the necessary qualification and validation documentation, including its structure and level of detail. The responsibilities of both suppliers as well as their regulated customers will be considered.
Hintergrund
“What is not documented has not been done!” The accurate documentation of all CSV activities is the prerequisite for successfully passing regulatory inspections as well as customer audits. On the other hand, creating the documents and maintaining their integrity is also time-consuming and costly. Here it is important to find a balance between “as few as possible but as much as necessary”.
Zielgruppe
This Live Online Training is directed at employees from the pharmaceutical industry and suppliers who have to prepare CSV documents and to document the validation activities of the computerised systems or who will have to carry this out in the future. Both beginners and employees with initial experience are addressed.
Technical Requirements
We use Webex for our live online training courses and webinars. At https://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
Qualification Documentation Overview
- Qualification / Validation Plan
- System Description
- Specifications
- Requirements management / requirement traceability
- Risk Management
- Verification
- Design Review, IQ, OQ, PQ
- FAT, SAT
- SOPs, agreements
- Qualification / Validation Report
- Qualification documentation scalability
Inspector’s Preconditions & Principles
- Guidelines
- Definitionen & Wording
- Overall Responsibility
- Essential PQS-Elements
- Lifecycle Approach IT-System
- Good Documentation Practice (incl. ALCOA)
Computerised System Validation: From Quality to CSV SOP and CS VMP
- Regulator expectations to the PQS
- PQS structure
- Quality Manual
- High level CSV SOP
- IT- / CS-VMP
CS-VMP and Inventory Lists
- CS VMP objective and purpose
- Planning / Reporting
- CS VMP structure proposal
- Management of the inventory lists
- Proposal for system classification
Inspector’s View to Structure & Documents
- Validation Structure
- Documentation Structure
- Essential Topics Project Phase (Validation)
- Essential Topics Operational Phase (Routine)
Supporting SOPs within a CSV Scope
- What SOPs?
- SOP structure proposal
- Recommendation
Data-/Documentation Management & Integrity
- Lifecycle Approach Data/Documents
- Identification of critical data/documents
- Lifecycle & Integrity Risk
- Data Governance Masterplan
Qualification / Validation Plan
- Objectives
- Responsibilities
- Structure proposal for a Qualification / Validation Plan
- Critical aspects
- Data flows
- Identification of the GxP relevant data
- Life cycle
- Risk management
- Overall acceptance criteria
- System release
Qualification / Validation Report - System Description
- Objectives
- Responsibilities
- Structure proposal
- Critical aspects
- Deviation from the planned procedure
- Failure and deviation handling
- Maintaining the qualified/validated state
- System Description
- Objectives
- Responsibilities
- Structure proposal
URS – User Requirements Specification
- URS objectives
- URS structure proposal
- Functional vs non-functional requirements
- Responsibilities
- Recommendation
Design Review: Supplier Documentation / Solution Selection
- Design review objectives
- Leveraging supplier effort
- Review of services offered
- URS vs system functionalities
- URS vs system support, e.g.: SLA
- Quality and usability of the user manual
- Quality and usability of technical documentation
- Design review report
- Consolidation of the qualification/validation process
FS – Functional Specification
- FS objectives
- How much is enough?
- When is a FS required / needed?
- What content?
- Responsibilities
- FS structure proposal
- Recommendation
- Process workflow and user roles
- Print-outs / reports
- Audit trail entries
CS – Configuration Specification
- CS objectives
- Responsibilities
- Structure proposal
- Content
- Recommendation
- When is a CS required / needed?
- Configuration report vs Configuration Specification
Project Design Revie
- Project consistency check
- Project approach
- Documentation
- Are the risk management outcomes properly taken into account?
- Are the audit report measures properly implemented
- Traceability matrix
- Design Review Report
Testing Documentation: IQ / OQ / PQ
- Installation Qualification (IQ) & Configuration Specification (CS)
- Operational Qualification (OQ) vs Functional Specification (FS)
- Performance Qualification (PQ)
- Scalability
- Recommendation: How to leverage FAT & SAT results?
Q/V Project Close Down
- Planning and supporting system handover
- Closing the Project
- Which documents are needed?
- Which documents need to be updated?
- Final system release
- Previous System Retirement
- Closing the Project
| ECA-Member*: | € 2090,- |
| Non ECA Member*: | € 2290,- |
| EU/GMP Inspectorates*: | € 1145,- |
| APIC Member Discount*: | € 2190,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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Weitere Termine vor Ort nicht verfügbar
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Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de
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