System Suitability Testing (SST) for USP and FDA Compliance
Instructor:
Dr. Ludwig Huber
Product ID: 702512
- Duration: 75 Min
Why Should You Attend:
System suitability testing (SST) is required by USP and FDA to check and ensure ongoing performance of an analytical systems and methods. Both USP and EP have chapters with recommendations for system suitability tests that are enforced by FDA and EMA. Related chapters have been updated by USP and EP and they also answer the question as to how much a method can be changed without the need for revalidation. Also, the USP chapter <1058> makes a statement that SST can substitute an instrument's performance qualification, but not further guidelines are given. So there are many questions. This webinar will give participants a good understanding of FDA and USP requirements for system suitability testing.
Areas Covered in the Webinar:
- FDA and international requirements for system suitability testing
- Examples of FDA warning letters and how to avoid them
- The role of SST for analytical quality assurance
- SST in comparison with equipment qualification and quality control sample analysis
- Most critical parameters for SST in EP and USP
- Contents of the updated USP chapter <621>
- Recommendations for implementing the updated <621>
- Developing an SOP for system testing
- Criteria for SST timing within a sequence of sample runs
- Using software for automated system suitability control
- The role of SST for method changes according to the updated chapter <621>
- Case studies with practical advice for test parameters and limits
- Documenting SST test runs
Who Will Benefit:
- Analysts
- Lab Supervisors and Managers
- QA Managers and Personnel
- QC Managers
- Consultants
- Teachers
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
- Understanding and Implementing USP <1058>: Analytical Instrument Qualification
- 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
Refund Policy
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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).
