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.
|Podcasts|March 4, 2022
Smart Manufacturing: Growing from Pilot to Production
This is the year in which manufacturers will have the courage to bet on data aggregation and AI solutions that help them grow their capacity, moving away from pilot mode and embedding those tools as foundational assets. These have become critical levers to support the expanded demand for drug manufacturing, especially exacerbated with the pandemic. Join John Vitalie, CEO at Aizon, as we discuss how Pharma 4.0 is transforming the pharma landscape to bring gains to manufacturers and to the patients they serve.
Related to this article
The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits in roughly 70% of small-molecule pipelines.
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.
FDA opens applications for its Expedited IND Pilot, pairing sponsors with qualified research institutions to test rolling CMC review ahead of first-in-human trials.
2026 approvals, clinical data, and licensing deals are advancing subcutaneous biologics, reducing patient burden, and reshaping biopharma drug strategy.
Karthik Iyer, Eli Lilly, details 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.
Trending on Pharmaceutical Technology
1
Driving Quality Culture to Manage Risk: Lessons from an FDA Inspection Response
2
FDA's IND Pilot Puts CMC Review First
3
Spray Drying Capacity Signals Faster Paths for Poorly Soluble Drugs
4
Mature Medicines Divestment Signals Shift in Manufacturing Strategy
5