Understanding and Implementing USP 1058 Analytical Instrument Qualification 2017

Topics

• 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)

Who should Attend

• 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