This Analytical Instrument Qualification training will guide you through Understanding of draft for analytical instrument qualification - Essential steps and recommendations for firmware and software validation.
Why Should You Attend:
Analytical instruments should be qualified to demonstrate suitability for the intended use. Companies are unsure on what exactly to qualify or re-qualify, test and document. The main reason is that unlike for analytical methods there was no clear standard with details for equipment qualification. This has changed. The USP has developed a chapter that provides a framework for analytical instrument qualification (AIQ).
This USP <1058> webinar will give a good understanding of current and future FDA requirements and the USP framework. It also will provide detailed steps, examples and tools for cost-effective implementation.
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).
Free Hand-outs :
For easy implementation, attendees will receive
- Copies of all slides
- SOP: Analytical Instrument Qualification
- SOP: Allocating Analytical Instrument to USP <1058> Categories
- SOP: Procedures and Deliverables for Qualification of USP <1058> Instrument Categories
Note: These complimentary hand-outs will be sent to customers on request. Please email customercare@complianceonline.com for these documents, stating your order number, and they will be emailed to you within 4 working days.
Who Will Benefit:
(Bio)Pharmaceutical Companies
Manufacturers of drug substances (APIs)
Contract laboratories
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
Instructor Profile:
Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance for Agilent Technologies. He is the editor of www.labcompliance.com , the global on-line resource for validation and compliance issues for laboratories. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare. For more information, visit Dr. Huber's website: www.ludwig-huber.com .
