Pooja Khemchandani joins Happy Biotech to share her journey from dentistry in India to TMF leadership in biotech. She breaks down what TMF health really means, how sponsor-side work differs from CROs, why the industry struggles with adopting new tech, and how automation and AI could reshape documentation. She also drops a spooky TMF story (yes—menus and hand scans happen) and reminds us of the ultimate rule: if it’s not documented, it doesn’t exist.
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Pooja Khemchandani joins Happy Biotech to share her journey from dentistry in India to TMF leadership in biotech. She breaks down what TMF health really means, how sponsor-side work differs from CROs, why the industry struggles with adopting new tech, and how automation and AI could reshape documentation. She also drops a spooky TMF story (yes—menus and hand scans happen) and reminds us of the ultimate rule: if it’s not documented, it doesn’t exist.
Happy Biotech - Audits, Inspections, and Dead Bodies in Closets
Happy Biotech
36 minutes 51 seconds
3 months ago
Happy Biotech - Audits, Inspections, and Dead Bodies in Closets
Suus and Micah dive into the surprisingly dramatic world of biotech audits and inspections, where FDA investigators can show up unannounced, silence is a weapon, and everyone's trained not to accidentally confess to crimes they didn't commit. From mock inspections to actual warrants being slammed on tables, discover why having zero deviations is more suspicious than having a few, and how strategic coffee breaks can save the day.
Warning: No actual bodies were harmed in the making of this podcast, but several egos may have been bruised during quality assurance reviews.
Happy Biotech
Pooja Khemchandani joins Happy Biotech to share her journey from dentistry in India to TMF leadership in biotech. She breaks down what TMF health really means, how sponsor-side work differs from CROs, why the industry struggles with adopting new tech, and how automation and AI could reshape documentation. She also drops a spooky TMF story (yes—menus and hand scans happen) and reminds us of the ultimate rule: if it’s not documented, it doesn’t exist.
