This message is sent to you by FDA Newswatch

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

Thursday, 21 June 2018  11:30 AM PDT, 02:30 PM EDT

Training Duration = 90 min                  Sponsored by Online Compliance Panel

Click Here to register $250.00

Click Here to register and receive CD recording $500.00

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.

Learning Objectives:

  • 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

Why Should You Attend:

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.

Topics

  • 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

Instructor

Greg Martin is the President of Complectors Consulting, which provides consulting and training in the area of Pharmaceutical Analytical Chemistry.

Mr. Martin has over 25 years experience in the pharmaceutical industry and was the Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years.

In addition, he has volunteered for the USP for over 10 years, and currently serves on the General Chapters - Chemical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules.

He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources.

Mr. Martin is the author of several papers in the areas of dissolution and analytical method validation, and was the past chair of the AAPS In Vitro Release and Dissolution Testing Focus Group.