Understanding and Implementing USP <1058>: Analytical Instrument Qualification
Instructor:
Dr. Ludwig Huber
Product ID: 700067
- Duration: 75 Min
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 Webinar:
- 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 [email protected] for these documents, stating your order number, and they will be emailed to you within 4 working days.
Who Will Benefit:
Dr. Ludwig Huber
Director and Chief Editor, Labcompliance
Dr. Ludwig Huber, Ph.D., is the director of Labcompliance and editor of www.labcompliance.com, the global online resource for validation and compliance. Dr. Huber is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems". He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies.
More Training By Experts
- Change Control for Computer Systems - strategies and tools for FDA compliance
- Master Planning for Computer System Validation
- Managing Failure Investigations and OOS Situations - Regulatory Requirements and Strategies for Implementation
- Effective Training for FDA Compliance: What to train - How much to Train - How to Document Effectiveness
- Validation of Analytical Methods and Procedures - Design, Conduct and Document for Efficiency and Compliance
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
