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.
News|Articles|September 2, 2005
- Pharmaceutical Technology-09-02-2005
- Volume 29
- Issue 9
The Nation Needs a Comprehensive Pharmaceutical Engineering Education and Research System
The pharmaceutical science education system must be transformed.
Advertisement
Articles in this issue
about 21 years ago
Securing the Supply Chain With RFIDabout 21 years ago
Applications of Poly(ethylene in Drug Delivery Systems: Part IIabout 21 years ago
Analytical Method Equivalency: An Acceptable Analytical Practiceabout 21 years ago
September 2005about 21 years ago
Pilots and Partnerships Move RFID Forwardabout 21 years ago
Reshaping CMC Development Servicesabout 21 years ago
Wash. Rinse. Repeatabout 21 years ago
Outsourcing Atrophy: A Cautionary Taleabout 21 years ago
In the Spotlight-September 2005Advertisement
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.
Advertisement
Advertisement
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
Mature Medicines Divestment Signals Shift in Manufacturing Strategy
4
Successful Internal Audit Planning and Execution
5