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|December 2, 2019
- Pharmaceutical Technology-12-02-2019
- Volume 43
- Issue 12
Two-step Disposable Autoinjector
BD’s new Intevia 1mL two-step disposable autoinjector, a device that combines an autoinjector and a pre-fillable syringe into one system, has a two-step, push-on-skin activation feature that allows the effective and safe injection of drugs of different viscosities up to 35cP and different fill volumes up to 1mL.
BD’s new Intevia 1mL two-step disposable autoinjector, a device that combines an autoinjector and a pre-fillable syringe into one system, has a two-step, push-on-skin activation feature that allows the effective and safe injection of drugs of different viscosities up to 35cP and different fill volumes up to 1mL. It also includes feedback indicators that visually show users when the correct dose has been delivered and triggers an audible click.
Additionally, the device can be adopted for a variety of drugs without customizing system components because of its patient-friendly design.
Articles in this issue
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Applying Lessons Learned from the Semiconductor Industryalmost 7 years ago
Visualization Enhances Facility Designalmost 7 years ago
Bio Diol and IEX Columnsalmost 7 years ago
Cube Plus for Pharmaceutical Manufacturingalmost 7 years ago
Triple Shaft Mixer with Powder Induction Manifoldalmost 7 years ago
Fighting the Good Fightalmost 7 years ago
Managing Excipient Interactionsalmost 7 years ago
‘Polling’ All the Wayalmost 7 years ago
The Challenges for Regulators in the Digital Agealmost 7 years ago
Tackling Solubility in Drug DevelopmentRelated 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.
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