The V-model has become a standard worldwide methodology for the validation of digital and computerized systems. Regulatory requirements, as well as industry guidelines, like GAMP®5, are orientated towards this model. But in Digital Transformation world, the validation execution should follow the principles of Quality and Data Integrity by Design which should call for Validation by design.
As a specialist for the validation of digital and computerized systems, this Live Online Training will provide you with:
- Suggestions on how current regulatory guidance on cloud computing and computerized systems relating to data integrity, critical thinking and Computer Software Assurance can be put into practice
- Approaches and principles of Validation 4.0 and Validation by design
- Real-life examples of how validation effort can be scaled according to risk-based approaches
- Cloud Infrastructure risk evaluation and qualification
- Answers to specific questions, e.g. on source code review or on creating specification documents
- The opportunity to bring questions from your own practice up for discussion
- Current Challenges and Evolution for CSV Activities
- GAMP5, 21 CFR Part 11, EU Annex 11, Data Integrity
- Roles, Responsibilities and Governance
- IT System Validation Lifecycle implementation and management
- Scalability of Validation Activities
- Writing Requirements Documents
- Requirements: The Good, the Bad and the Ugly
- Effective Content of a CSV SOP
- Data Integrity and Record Management
- Design Review – How to Apply Critical Thinking
- Bringing Legacy Systems into Compliance
Participants will receive a copy of the presentation(s), relevant notes and Master Class materials. A certificate of completion will be issued to participants.
A written assessment could be conducted if necessary at the end of the course.
Language of instruction: The course will be held in English.
The Master Class is directed at employees from:
- Quality Assurance
- Quality Control
Participants should already have gained experience in the validation of computerized systems, and preferably will have also attended a basic CSV Course.
Kossi Molley, LSSBB, Chartered Trainer – Managing Consultant