Quality Systems

Videos

Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates, joins PDA CEO Glenn Wright and Melissa Seymour, Executive Vice President, Global Quality, Eli Lilly and Company, to talk about the regulatory and quality topics discussed at the 2025 PDA Regulatory Conference. 

PDA Regulatory Conference 2025: Wrap Up

Michelle Heiter is laboratory and quality control specialist at Regulatory Compliance Associates, a Nelson Labs Company.

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Articles

Michelle Heiter, laboratory and quality control specialist, and Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates, a Nelson Labs Company, discuss how to effectively use contamination control strategies in your operations.

Effectively Using Contamination Control Strategies

EMA and WHO have collaborated for a decade, with WHO utilizing EMA’s scientific expertise to fulfill its mandate to improve access to safe and effective medicines.

EMA and WHO Celebrate 10-Year Collaboration

Unichem Pharmaceuticals has issued a voluntary recall of Cyclobenzaprine Hydrochloride Tablets USP 10 mg after the incorrect label was placed on the wrong product.

Mislabeling Leads to Cyclobenzaprine Hydrochloride Recall

Patrick Falvey is principal consultant 2 of Chemistry Manufacturing and Controls, Sia/LBG.

Georgia Sloboda is managing director of Chemistry Manufacturing and Controls, Sia/LBG.

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

Lauren Schoukroun-Barnes, PhD, is associate manager of Regulatory Affairs,  Sia/LBG.

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

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

Gail Reed is senior scientist with Johnson & Johnson.

Joseph A. Albanese, director of Analytical Strategy and Compliance at Janssen Research and Development, LLC

Yelena Ionova is senior manager, Data Strategy and Analytics with Redica Systems.

J. Mark Wiggins is owner and compendial consultant with Global Pharmacopoeia Solutions LLC.

The authors propose a streamlined, efficient approach to determining specification equivalence that starts with a paper-based assessment of the methods and progresses to a data assessment for the methods under evaluation.

Specification Equivalence: A Practical Approach to Method and Acceptance Criteria Equivalence

Cheryl Barton is director of PharmaVision, 

The deadline for stakeholder consultation submissions on the new and updated regulations is Oct. 7, 2025. 

Stakeholders’ Consultation on GMP Annex 11, Chapter 4, and New Annex 22 

John Schallom is senior technical services Associate, STERIS.

Brian Bosso is technical services manager, STERIS.

Paul Lopolito is a technical services specialist at STERIS, Mentor, OH.

Katie Frey is formulation manager, STERIS.

Amy Thanavaro is R&D scientific manager, STERIS.

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

In-line UV Spectrometry Monitoring in Cleaning Validation

George Francis Tidmarsh, MD, PhD, founding co-director of Stanford’s Master of Translational Research and Applied Medicine program, has been appointed as the new director of the Center for Drug Evaluation and Research.

FDA Appoints New CDER Director, George Tidmarsh

Alan M. Mancini, RPh, is a pharmaceutical scientist.

Nishant B. Thakar, RPh, PharmD is assistant professor Clinical Sciences, Roosevelt University College of Science, Health, and Pharmacy.

Varanya Chaiyaperm, RPh, PharmD is clinical assistant professor, University of Illinois College of Pharmacy.

An ordered pharmaceutical compounding process for use in 503A pharmacies, 503B outsourcing facilities, pharmaceutical industry, and other applications.

Quality Assurance/Quality Control