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. The USP has developed a new standard for analytical instrument qualification (AIQ). It will be official by August 1, 2008.
Why Should You Attend:
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 is changing. The USP has developed a new standard for analytical instrument qualification (AIQ). It will be official by August 1, 2008. When implemented right the standard also helps to reduce overall qualification costs.Areas Covered in the seminar:
- FDA and EU requirements for analytical instrument qualification.
- Most common inspection problems.
- Terminology, scope and principles of the new USP chapter.
- 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 equipment qualification phases: design qualification, installation qualification, operational qualification, performance qualification.
- Recommendations for firmware and software validation.
- Roles and responsibilities: QA, manufacturer, user.
- Approach for automated systems (incl. firmware/computer systems).
- Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade).
- What documents should be available for the FDA.
Who Will Benefit:
- Everybody involved in analytical instrument qualification
- Laboratory Managers
- QA managers and personnel
- Analysts
- Metrology groups
- Validation specialists
- Suppliers of analytical equipment
- Regulatory affairs
- Training department
- Consultants
Course Provider
Dr. Ludwig Huber,
