In this Risk Based Validation training we will go through various scenarios and recommend actions for validation and other controls.
What Attendees will Learn:
Why Should You Attend:
Recent FDA and industry guidances recommend to base the extent of validation of computer systems and other controls on risk assessment. Examples are FDA’s Part guidance, GAMP4, ISO and ICH Q9. Frequently risk categories are easy to define but the real challenge comes when users should take action to optimize risks versus costs. In this interactive web seminar we will go through various scenarios and recommend actions for validation and other controls.What Attendees will Learn:
- FDA/EU and business requirements
- Guidance from regulatory and industry task forces: ISO, ICH, GHTF, NIST, GAMP/ISPE
- Practical approach for risk assessments
- How to develop a risk based software and computer validation program
- Validation tasks for risk categories for each life cycle phase- Planning, design and specifications, vendor assessment, installation, testing, change control, back-up, contingency planning
- Validation tasks segmented by system complexity
- Documenting the decision for management and for the FDA
- Examples and specific recommendations from laboratories, office computers and production
Who Will Benefit:
- Validation specialists
- IT specialists
- QA managers and personnel
- Software developers
- Users of software and computer systems
- Regulatory affairs
- Training department
- Documentation department
- Consultants
Course Provider
Dr. Ludwig Huber,
