New Revision of USP <1058>: Analytical Instrument Qualification 2018 covers topics such as:
- AIQ and its relation to method validation, system suitability testing and quality control checks
- Changes to the previous chapter
- The 4Q Qualification lifecycle approach: DQ, IQ, OQ, PQ
- Approaches for risk based qualification: where does risk assessment start
- How to develop agreements with suppliers of equipment and service`?
- Purpose and contents of equipment qualification phases: design qualification, installation qualification, operational qualification, performance qualification
- Integrating software validation and equipment qualification
- Requirements for outsourcing AIQ implementation
- Recommendations for effective implementation of the new chapter
- Dealing with changes of software, firmware and equipment hardware
- Expected timing of FDA enforcement
New Revision of USP <1058>: Analytical Instrument Qualification 2018 intended for:
- GLP/GCP/GMP auditors
- Laboratory managers and supervisors
- QA/QC managers and personnel
- ISO 17025 auditors
- Regulatory affairs
- Analysts and other laboratory staff
- Consultants
- Training departments
