Are you new to qualification and validation? This 2-day course will give you the basic knowledge for a risk-based approach for both process equipment and computerized systems in Life Science. Theory and information are interspersed with concrete practical exercises during the course days.
Who should attend?
The course is aimed at those who are in the initial phase of their work with qualification and validation and who need basic knowledge and understanding of risk-based qualification and validation of process equipment and computerised systems. The course is suitable for those working as e.g. operators, process engineers, validation engineers, QA or suppliers.
Course goal
After the training days you will:
Have a basic knowledge of the qualification and validation process for process equipment and computerised systems,
Be able to apply risk-based approach and tools to prevent and solve problems,
Be able to drive and participate in the qualification and validation process in different roles (e.g. validation engineer, process engineer, operator, QA, project manager).
Course contents
The training days consist of lectures, interspersed with real-life examples, discussions and practical exercises.
Introduction to regulatory requirements
Risk-based validation and qualification process
Requirements Definition
Validation planning and strategy
Supplier responsibility FAT&SAT
Risk Review
Deviation and change management
Qualification report
Validation, Process Validation, Cleaning Validation
Roles and responsibilities
Qualification of process equipment and computerised systems
Cloud solutions (Software as a Service, SaaS)
Program
Time and place
The training day will be held on 18-19 October at Apotekarsocieteten, Wallingatan 26A , Stockholm. Training day 1 starts at 09.00 and ends at 17.00. Registration and breakfast from 08:30. Training day 2 starts at 08:30 and ends at 17:00.
