Susan Haigney is lead editor of BioPharm International®.
Ask the Expert: Complying with 21 CFR 211.110
February 20th 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Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss the implications of FDA’s new draft guidance on complying with 21 CFR 211.110.
Ask the Expert: Product Inspection, Part One; Risk Mitigation in Secondary Packaging
January 23rd 2025Dirk Margosch, Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, provides advice on how to respond to defective vials in a batch and how to prevent future problems in secondary packaging.