Amid several other critical discussions, this training program will detail FDA and international requirements for system suitability testing; SST in comparison with equipment qualification and quality control sample analysis; critical parameters for SST in EP and USP; recommendations for implementing the updated <621>; and developing an SOP for system testing.
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:
For easy implementation, attendees will receive:
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.
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. FDATrainingAlert 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.
If you have any concern about the content of the webinar and not satisfied 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 firstname.lastname@example.org call +1-888-771-6965 (Toll Free).
This product hasn't received any reviews yet. Be the first to review this product! Write review