Training Course Syllabus:

System Suitability Testing for FDA and USP Compliance

Time: 10:00 AM PDT | 01:00 PM EDT

Duration: 75 Minutes

Instructor: Dr. Ludwig Huber

Description:

System suitability testing (SST) is required by USP and FDA to check and ensure on-going performance of analytical systems and methods. Both USP and EP have chapters with recommendations for system suitability tests that are enforced by FDA and other agencies. 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. This webinar will give a good understanding of FDA and USP requirements for system suitability testing.

Why Should you Attend:

Attend this session to understand more on FDA and USP requirements for system suitability testing explained with the help of case studies and gain practical advice for test parameters and limits.

Objectives of the Presentation:

This training on Credit Card Program Benchmarking will cover the following areas:

• 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 new 621


• Developing an SOP for system testing


• Criteria for SST timing within a sequence of sample runs


• The role of SST for method changes according to the new chapter 621


• Recommendations for non-chromatographic systems

Who can Benefit:

• Laboratory managers and supervisors


• Quality Assurance Managers


• Develops of spreadsheet applications


• All users of Excel used in regulated environments


• QA managers and personnel


• GMP auditors


• Consultants

Seminar Summary:

System suitability testing (SST) is required by USP and FDA to check and ensure on-going performance of analytical systems and methods. Both USP and EP have chapters with recommendations for system suitability tests that are enforced by FDA and other agencies. 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. This webinar will give a good understanding of FDA and USP requirements for system suitability testing. (see full course description)

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