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System Suitability Testing (SST) for USP and FDA Compliance

Thursday June 14 2018  10:00 AM PDT | 01:00 PM EDT

Training Duration = 75 Min                    Sponsored by Compliance Online

Click Here to register $349.00

Click Here to register and receive recording $199.00

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.

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

  • 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

Hand-Outs:

For easy implementation, attendees will receive:

  • SOP: System Suitability Testing in Chromatography
  • SOP: Change Versus Adjustment of Compendial Methods
  • Example Protocols for Occasional and Ongoing System Suitability Tests
  • Checklist: System Suitability Testing

Instructor

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.