FDA Inspections
5 videos · last 6 months shuffled daily, then older videos newest first
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58:32 Sponsor Oversight of CROs: Practical Strategies
Phortas presents a webinar for biotech sponsors on CRO oversight, covering regulatory expectations, vendor governance, KPIs, sponsor oversight plans, oversight visits and inspection readiness.
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14:42 Season 5, Episode 5: Preparing for FDA Inspections Before They Happen
EMMA International on building continuous FDA inspection readiness, from aligning procedures with practice to internal audits, mock inspections and CAPA management.
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6:46 The Inspection XII - Update 2026
GCP-Service International on its recent GCP inspection, from the draft inspection report to final implementation.
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40:18 TMF Inspection Readiness with Chad Scribner
Chad Scribner, senior consultant at Epista Life Sciences, discusses TMF inspection readiness on the TMF Daily podcast, including risk-based TMF reviews, ancillary systems, meaningful metrics and the red flags inspectors spot.
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55:04 D1S03 - Clinical Trials with Decentralized Elements
The FDA sets out its Good Clinical Practice expectations for trials with decentralized elements, covering risk assessment and what its inspections have found.