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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Top 10 GMP Audit Citations: FDA & TGA Inspections
FDA & TGA GMP Compliance Audit Citations for 2020 – 2024. Latest FDA inspection trends: common audit findings…
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FDA Warning Letters – CAPA
FDA Warning Letters for cGMP compliance issues relating to CAPAs If you’re a Pharmaceutical business owner or Quality…
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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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Pharmaceutical Industry Jobs: 5 Essential Skills
What are the requirements for applying for pharmaceutical industry jobs? Are you applying for current Pharmaceutical industry job openings? If…
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Industry Updates: PDA and FDA Joint Regulatory Conference
Our GMP courses, e-learning courses and GMP Forums repeatedly get great reviews by people who need to know…
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Does my product require FDA approval?
FDA Pre-Approval Requirements Will your product need pre-approval from the FDA before you can sell it to the…
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