Analytical Instrument Qualification and System Validation

Topics

• Logic and principles of instrument qualification and system validation from validation planning to reporting
• Regulatory background and requirements for laboratory instrument qualification and system validation
• Execute test protocols, including setting specifications and acceptance criteria
• Company’s qualification and validation strategies
• Developing inspection ready qualification and validation deliverables
• How to review and approve qualification and validation protocols
• How to avoid and/or respond to FDA inspectional observations and warning letters

Who should Attend

Personnel in pharmaceutical development and quality control laboratories and contract testing laboratories, including:

• QA managers and personnel
• IT/IS managers and system administrators
• Analysts
• Laboratory managers and supervisors
• Software developers
• Validation specialists
• Training departments
• Regulatory affairs
• Consultants
• Documentation departments