PDA Regulatory Conference

Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.

PDA/FDA 2026 session maps the GMP audit lifecycle, root cause to CAPA closure, plus a local vs. above-site decision framework and two case studies.

Lori Dingledine, QC Director Microbiological Control and GTIC Operations at Genentech, provided input on the regulations surrounding raw material manufacturing and use for ATMPs in a presentation at the 2026 PDA/FDA Joint Regulatory Conference.

Karthik Iyer, Eli Lilly, detailed an AI system linking GMP findings, audits, and deviations for cited, inspection-ready regulatory intelligence.

At the PDA/FDA Joint Regulatory Conference 2026, Helen Motamen, MS global head, Sanofi Quality Audit, Inspection, Intelligence & Advocacy, at Sanofi, provided advice for creating a strong internal audit program.

At PDA/FDA Joint Regulatory Conference 2026, PCI Pharma's Bassler details how a QMS overhaul turned an FDA 483 into stronger quality culture.

Advanced automation in biopharma facilities secures product quality, assures compliance, and improves efficiency.

Merck’s Sanat Chattopadhyay called for stronger leadership, data-driven oversight, and shared accountability to raise pharmaceutical quality standards.

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.

AI can offer a strategic blueprint for GxP compliance, risk mitigation, and human-led operational excellence.

FDA experts at PDA 2025 urges pharma to adopt holistic quality systems, strengthening 483 responses & post-warning letter remediation for compliance excellence.

Charles Gibbons of Lachman Consultants and Michael Grischeau of AbbVie stressed AI governance, data integrity, and human oversight as essential to applying digital tools across labs and supply chains.

Bothe data integrity and quality of data are critical for drug discovery, manufacturing efficiency, regulatory compliance, and patient safety.

Glenn Wright previews the 34th PDA Regulatory Conference, spotlighting AI, quality culture, FDA trends, and collaboration shaping industry progress.

The PDA Regulatory Conference convenes more than 30 FDA experts to discuss cGMP excellence, compliance trends, and regulatory outlook, offering crucial insights for pharma manufacturing professionals.