System Suitability Testing in the Pharmaceutical Laboratory: Addressing FDA and USP Compliance

Live Webinar: System Suitability Testing in the Pharmaceutical Laboratory: Addressing FDA and USP Compliance Wednesday Sep 22, 2021 - 03:00 PM Duration: 90 Minutes.

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Due to the criticality of the data generated in a pharmaceutical laboratory, System Suitability Testing (SST) has been implemented to provide input on a daily basis about whether or not an analytical method is performing as intended. 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.

Areas Covered:
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