System Suitability Testing (SST) for USP and FDA Compliance

MessageThis Webinar is over
Date Sep 17, 2018
Time 03:00 PM EDT
Cost $17125.00
System suitability testing (SST) is required by USP, FDA and EP to check and ensure on-going 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 seminar will give a good understanding of FDA and USP requirements for system suitability testing. After the seminar best practice documents will be available for easy implementation. Examples for such documents are SOPs. checklists and examples.
For easy implementation, attendees will receive:
  • SOP: System Suitability Testing in Chromatography
  • Checklist: System Suitability Testing
Areas Covered in the Session :
  • 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 Should Attend:
  • Research and Development Departments
  • Quality Assurance Departments
  • Quality Control Departments
  • Laboratory Personnel
  • Analysts
  • API Manufacturers
  • Contract Laboratories
  • CROs
  • Consultants


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