Medical Device Recalls – Early Alerts System (FDA Pilot Expansion)
On 29 September 2025, the FDA announced that the pilot program for rapid medical device recall communications (the…
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Medical Device Design
Medical device design should consider – at the earliest of design stages – manufacturing licence application requirements, regulatory compliance requirements, material supply chains and reactivity, and manufacturing at scale.
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Are you ‘recall ready’ according to the FDA?
Are you ‘recall ready’? What do regulators such as the FDA, TGA, EMA or MHRA expect in terms of recall preparedness? Recall basics.
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Medicine Supply Shortages
Medicine supply shortages relating to the pandemic continue to wreak havoc on treatment continuity. GMP education can help reduce shortages caused by …
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FDA Warning Letters on Data Integrity Issues
Batch release decisions — and other product safety evaluations — rely on data integrity. In this pharmaceutical industry…
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Get ready for an Audit
Get ready for an audit (how to train your employees) Need to get ready for an audit? How…
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Remote Inspections (Offsite Inspections)
Remote inspections: FAQs Remote Inspections & Offsite Auditing 10 Commandments for Conducting Remote Inspections (offsite inspections) FAQ 1:…
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Non-Clinical and Clinical Trials: Drug Safety Monitoring Training
These courses are suitable for laboratory and clinical researchers who need to understand their legal responsibilities in non-clinical…
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Medical Supply Chain Risks: Vulnerabilities and the Importance of GMP
Lean manufacturing and ‘just in time’ shipping strategies means medical supply chain risks are an ever-present phenomenon. But medical…
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