Analytical Instrument Qualification and Validation: Understanding to Prepare for FDA Audits to become Part 11 Compliant 2016

Key Topics

• The logic and principles of instrument qualification and system validation from validation planning reporting
• The regulatory background and requirements for laboratory instrument qualification and system validation
• Independently prepare execute test protocols, this includes setting specifications and acceptance criteria
• The company`s qualification and validation strategies
• Develop 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

Attendees from:

• IT managers and staff
• Laboratory managers, supervisors and analysts
• Laboratory suppliers of material, equipment and services
• Consultants
• Quality professionals
• Senior quality managers
• Compliance professionals
• Regulatory professionals
• Validation engineers
• Production supervisors
• Production engineers
• Manufacturing engineers
• Process owners
• Design engineers
• Quality auditors
• Quality engineers