The Analytical Instrument Qualification and Validation: Understanding to Prepare for FDA Audits to become Part 11 Compliant 2016 is a seminar that covers topics such as:
- 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
The Analytical Instrument Qualification and Validation: Understanding to Prepare for FDA Audits to become Part 11 Compliant 2016 brings together 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
