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
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.
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.
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.