Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.
Ask the Expert: Identity Testing on a Final Product
July 24th 2025In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss if and when identity testing is necessary to be performed on a final product when the API is sourced from a third party.
Ask the Expert: Quality Control Units
May 22nd 2025In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss how to address an FDA warning letter citation for a failure to establish a quality control unit.