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.
|Articles|October 2, 2001
- Pharmaceutical Technology-10-02-2001
- Volume 25
- Issue 10
System Optimization for In Situ Fiber-Optic Dissolution Testing: Hydrodynamic Effects, System Performance, and Applications
Testing of an in situ fiber-optic transmission probe demonstrates sound hydrodynamic performance and reduced stray-light limitations.
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Articles in this issue
almost 25 years ago
Outsourcing Outlookalmost 25 years ago
Hydrogels for the Controlled Release of Pharmaceutical Proteinsalmost 25 years ago
Near-Infrared Inspection Complements Other QC Systemsalmost 25 years ago
Safety and Manufacturing Standardsalmost 25 years ago
Current Status of the Oral Delivery of Insulinalmost 25 years ago
Laboratory Equipment Qualificationalmost 25 years ago
Filter Integrity Testing in Liquid Applications, Revisited, Part Ialmost 25 years ago
360° Feedback - Improving the Selection Process All the Way AroundAdvertisement
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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.
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