Risk-Based Validation of Laboratory Computerised Systems MasterClass

Topics

• The impact of cloud computing on computer validation projects
• Advantages and disadvantages of the FDA’s Computer Systems Assurance approach
• Apply risk management throughout a life cycle of a computerised system
• Applicable regulations and guidance for AIQ and CSV

Who should Attend

• Computer validation personnel
• Laboratory managers, supervisors and analytical scientists responsible for instruments and systems
• IT staff responsible for regulated computerised system
• Quality assurance