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Training
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- Elaboration of training modules for both:
- Classroom training (including paper documentation)
- Computer based training (e-learning)
- Organization and moderation of workshops by customers
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Quality Risk Management (according to ICH Q9)
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Training for:
- Business & process owner, system owner
- Project manager
- Project team member
- System / software developer
- Management members
- Member of quality units (e.g. Quality Assurance)
Modules:
- Introduction to ICH Q9
- ICH Q9, ASTM E2500-13, GAMP® 5
- High Level Risk Assessment (HLRA)
- System Risk Assessment (SRA)
- Functional Risk Assessment (FRA)
- Risk management and optimization of the test effort
- Tools & methodology: FMEA, HAZOPS, ...
- Risk based approach for projects
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Good Engineering Practices
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Training for:
- Business & process owner, system owner, users
- Project manager
- System / software developer
- Management members
- Member of quality units (e.g. Quality Assurance)
Modules:
- Lifecycle
- Elaborating good requirements and specifications
- Requirement management, requirement identification
- Configuration management
- Change management
- Design review
- Test management
- Data management / record management
- System management
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e-Compliance / Electronic compliance
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Within the regulated industry - in particular in the healthcare sector -, e-Compliance covers generally at least Computerized System Validation (CSV) and all topics related to the correct use and management of electronic records and electronic signatures (ERES).
Training for:
- System owner, users
- Project manager
- System / software developer
- Management members
- Members of quality units (e.g. Quality Assurance)
Modules:
- cGxP compliant lifecycles
- Requirement management, traceability matrix
- Data integrity
- Test management
- Configuration management
- Compliance and project management
- Data management / record management
- Electronic data archiving
- System management
- Introduction to EU's Annex 11 and 21CFR Part 11
- Annex 11 and 21CFR Part 11: rules and examples
- CSV-case study : the inspector/auditor point of view
- History of the validation
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