Analytical Instrument Qualification & Validation - Use of Excel and FDA Audit Preparation 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
- How to independently prepare and execute test protocols, this includes setting specifications and acceptance criteria
- Company’s qualification and validation strategies
- Validation and Use of Excel in the QC Laboratory
- How to review and approve qualification and validation protocols
- Developing inspection ready qualification and validation deliverables
- Handling raw data and other laboratory records
- How to avoid and/or respond to FDA inspectional observations and warning letters
Analytical Instrument Qualification & Validation - Use of Excel and FDA Audit Preparation brings together:
- 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
