USP 1058 Analytical Instrument Qualification - 2017

Overview:

• Product Id : 501092
• Instructor : Dr. Ludwig Huber
• Wednesday, April 19, 2017   |   10:00 AM PDT | 01:00 PM EDT   |   Duration: 75 Minutes

Analytical instruments should be qualified to demonstrate suitability for the intended use. Despite the fact that instrument qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters.

Companies are unsure on what exactly to qualify or re-qualify, test and document. The main reason is that unlike for analytical methods there are no clear standards for equipment qualification. This has changed. The USP has developed a new standard for analytical instrument qualification (AIQ).

Reference material for easy implementation:

• SOP: Analytical Instrument Qualification for <1058>
• SOP: Allocating Analytical Instruments to USP <1058> categories
• SOP: Procedures and deliverables for USP <1058> categories

Areas Covered in the Session:

• FDA and EU analytical instrument requirements
• Most common inspection problems
• Terminology, scope and principles of US chapter <1058>.
• AIQ and its relation to method validation, system suitability testing and quality control checks
• Essential steps for AIQ: DQ, IQ, OQ, PQ
• Purpose and contents of design qualification, installation qualification, operational qualification, performance qualification
• Allocation of instruments to the three categories A, B and C
• Procedures and validation deliverables for the three categories
• Recommendations for firmware and software validation
• Roles and responsibilities: QA, manufacturer, user
• Approach for automated systems (incl. firmware/computer systems)
• Qualification of existing systems
• Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade)
• Recommendations for effective implementation

Who Will Benefit:

• Laboratory Managers and Staff
• Analysts
• QA Managers and Personnel
• Regulatory Affairs
• Training Departments
• Documentation Department
• Consultants
• Validation Specialists
• Regulatory Affairs
• Training Departments
• Documentation Department
• Consultants

Speaker Profile

Ludwig Huber Ph.D., is the director and editor of Labcompliance the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare". He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world.

Others Details

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