Objectives of the Presentation
Why Should you Attend
- Understand the FDA and USP Requirements for System Suitability Testing
- Learn which parameters should be included in SST, and how they relate to USP General Chapter <621>
- Understand how SST, Instrument Qualification and Quality Controls are related, and how they are different
- Learn what to do if your method fails to meet SST requirements
This webinar will address the rationale behind System Suitability Testing, how to establish SST as an effective Analytical Control Strategy and what to do if SST does NOT conform to the expectations. We will discuss USP General Chapter <621>, including which analytical parameters may be adjusted to achieve passing SST results.
Who will Benefit
- FDA and USP Requirements for System Suitability Testing (SST)
- System Suitability Testing as an integral part of Analytical Control Strategy
- Which Parameters should be included in SST?
- How does SST relate to USP <621> Chromatography
- What if you fail the SST criteria?
- Understanding the relationship among SST, Instrument Qualification and Quality Control Samples
- Recommendations for non-chromatographic methods
- Attendee Questions
Chemists (Research, Quality Control, and CRO; Human, Veterinary, Generic or Dietary Supplements) involved with dissolution method development or testing and their managers, QA personnel responsible for reviewing investigations, formulators who rely on dissolution data and regulatory affairs/CMC personnel responsible for filings involving dissolution, Laboratory managers and supervisors , Quality Assurance Managers , GMP auditors ,Consultants.
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.