This Validation training will give a good understanding on what the requirements are and how to validate laboratory computer systems in the most cost-effective way.
What Attendees will Learn:
Why Should You Attend:
Laboratory systems are amongst key targets of FDA inspections. They are considered high risk systems because they can have a high impact on product quality. Validation can be a challenge because laboratory computers become more and more automated. And automated systems are more and more networked so the question is how to validate networks. Last but not least programs are readily available for customization such as Macro programs and spreadsheet applications, they need to be validated, too. This seminar will give a good understanding on what the requirements are and how to validate laboratory computer systems in the most cost-effective way.What Attendees will Learn:
- FDA and EU requirements for laboratory computers - What do inspectors ask and what documents should be available
- Most frequently cited deviations related to laboratory computers
- How to develop a validation master plan for laboratory computers?
- How to write a user requirement specification document?
- Validation steps: DQ/IQ/OQ/PQ
- Recommendations for risk based validation
- How to ensure and validate spreadsheet integrity
- How to ensure system security and data integrity
- Qualification of laboratory network infrastructure
- Qualification of laboratory network infrastructure
- Validation of networked systems
- How to document planning, specifications, installation, testing and changes
Who Will Benefit:
- Lab Supervisors and Managers
- QA managers and personnel
- Internal auditors
- Analysts
- IT managers and personnel
- Consultants
- Teachers
Course Provider
Dr. Ludwig Huber,
