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[August 2022 Issue] FDA Resumes Inspections, But Keeps Remote Alternatives. Inside the…Watch now (27 min) | Regulators are restarting inspections while hanging onto remote reviews. The QSR may finally be harmonized with ISO 13485. And we look at lapses in validation and testing.
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[July 2022 Issue] Proposed CGMP Requirements for Compounding Facilities, SaaS & SaMD: Harmonizing QSR with IEC 62304 + Warning Letter…Watch now (24 min) | Minimum CGMP requirements may be formally coming to compounding facilities. We also look at SaaS and SaMD through the lens of QSR…
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[Free Sample Issue] Another Take on FDA's Remote Inspection Authority for Devices, Updates to Software Documentation in Pre-Market…Watch now (12 min) | We dive deeper into expanding FDA's authority to remotely review device companies, outline changes to pre-market submissions for…
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[Free Sample Issue] FDA Ramps Up Inspections, Enforces More from Inspection Alternatives, and Seeks to Extend Remote Review Authority to…Watch now (24 min) | The agency exceeded its own inspection expectations last year. It also made more drug enforcement actions based on inspection…
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