ComplianceOnline

System Suitability Testing (SST) for USP and FDA Compliance

Instructor: Dr. Ludwig Huber
Product ID: 702512
  • Duration: 75 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$299.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

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Read Frequently Asked Questions

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 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

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

Who Will Benefit:

  • Analysts
  • Lab Supervisors and Managers
  • QA Managers and Personnel
  • QC Managers
  • Consultants
  • Teachers

Instructor Profile:

Ludwig Huber, Ph.D., is the director of Labcompliance and editor of www.labcompliance.com, the global online resource for validation and compliance. He 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 includes seminars, workshops and presentations for the US FDA, China CFDA, , ISPE, PDA, PIC/S and several other industry organizations and national health care agencies.

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