New Revision of USP <1058>: Analytical Instrument Qualification 2018

Topics

• 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

Who should Attend

• 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