Understanding and Implementing USP 1058 Analytical Instrument Qualification 2017 is a webinar that covers topics such as:
- Most common inspection problems
- FDA and EU analytical instrument requirements
- AIQ and its relation to method validation, system suitability testing and quality control checks
- Terminology, scope and principles of US chapter (1058)
- Purpose and contents of design qualification, installation qualification, operational qualification, performance qualification
- Essential steps for AIQ: DQ, IQ, OQ, PQ
- Procedures and validation deliverables for the three categories
- Allocation of instruments to the three categories A, B and C
- Roles and responsibilities: QA, manufacturer, user
- Recommendations for firmware and software validation
- Qualification of existing systems
- Approach for automated systems (incl. firmware/computer systems)
- Recommendations for effective implementation
- Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade)
Understanding and Implementing USP 1058 Analytical Instrument Qualification 2017 is intended for:
- Analysts
- Laboratory Managers and Staff
- Regulatory Affairs
- QA Managers and Personnel
- Documentation Department
- Training Departments
- Validation Specialists
- Consultants
- Training Departments
- Regulatory Affairs
- Consultants
- Documentation Department
