Authors

Sarah DeDonder

Sarah DeDonder, PhD, is manager of Quality Assurance with Sia/LBG.

Latest Article

New Year, Same Challenges: Pharma’s Ongoing Struggle with FDA 483s

The authors examine common FDA 483 findings and outline strategies to address and prevent regulatory non-compliance.

Christopher Ziegenfuss

Christopher Ziegenfuss is Vice President, at BioPharmaSpec, Inc

Latest Article

ICH Q6B for Analytics

ICH Q6B provides expectations and a clear framework for the structural characterization of biopharmaceutical products.

Rona LeBlanc-Rivera, PhD

Rona LeBlanc-Rivera, PhD, is principal consultant, Regulatory Affairs at Regulatory Compliance Associates.

Latest Article

Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.

Piyush Gupta

Piyush Gupta is an expert pharmaceutical consultant based in Bengaluru, India.

Latest Article

Microplastics as Vectors of Pharmaceuticals in Ecosystem: A Concern

While plastics have revolutionized pharmaceutical packaging, that evolution within the industry has come at a cost.

Amy Thanavaro

Amy Thanavaro is R&D scientific manager, STERIS.

Latest Article

In-line UV Spectrometry Monitoring in Cleaning Validation

The authors performed interference and enhancement testing using a formulated alkaline and acid cleaner, as well as common biopharmaceutical process residues.

Felicity Thomas

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Latest Article

Industry Outlook 2025: European Political Impacts on the Supply Chain

The PharmTech Group interviewed Edwin Stone, CEO of Cellular Origins, about how geopolitical instability in Europe, and beyond, has impacted the bio/pharmaceutical supply chain.

Andy Studna

Andy Studna is a senior editor for Pharmaceutical Executive and Applied Clinical Trials. He can be reached at astudna@mjhlifesciences.com.

Latest Article

CNPV Deep Dive: Perspectives on Accelerated FDA Review From the C-Suite to the Manufacturing Floor

Industry experts talk with PharmTech, Pharmaceutical Commerce, Applied Clinical Trials, and Pharmaceutical Executive about FDA's CNPV pilot program.