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AICA in the Quality Department: How to Actually Use it Day to Day
Where our AI-powered auditing tool fits in the everyday work of a Quality team.
Jun 25
•
The FDA Group
3
1
Guidance Breakdown: FDA Highlights Postapproval Requirements and Resources for ANDAs
The FDA is pulling postapproval reminders out of ANDA approval letters. We break down the new reference guidance that replaces them and the obligations…
Jun 24
•
The FDA Group
3
1
What the First QMSR Inspections Reveal: Familiar Problems, a Sharper Lens
The FDA says it's now run more than 100 inspections under the new rule. The top findings are not a huge surprise. Where they're surfacing is the real…
Jun 22
•
The FDA Group
8
1
Aurion Biotech's Chief Regulatory and Quality Officer on Leading When There's No Clear Right Answer
Sterling Chung on servant leadership, the trust formula, distilling emotion out of hard decisions, and why the last thing you do for someone is half of…
Jun 19
•
The FDA Group
3
1
51:01
RA/QA News Roll: Mid June 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
Jun 18
•
The FDA Group
4
1
NeuraSignal's VP of Quality on Why Your CAPA System Isn't Driving Improvement (and How to Fix It)
Dan Eagles explains the back-engineered root cause, the "retrain the operator" trap, and how to rebuild CAPA into a tool people actually want to use.
Jun 15
•
The FDA Group
4
1
27:51
Why Your CAPA System Isn't Driving Improvement (and How to Fix It)
Why do so many CAPA systems pass their metrics while the same problems keep coming back?
Jun 15
•
The FDA Group
27:51
One Way to Interrogate "Human Error" in CAPAs
An approach to a specific, recurring problem that has held up well in practice.
Jun 12
•
The FDA Group
13
Eric Boyd Introduces the Latest Version of AICA in 3 Minutes
A brand new demo of the Audit Intelligence Compliance Assistant.
Jun 12
•
The FDA Group
3
1
2:59
A Few Lessons From Our Recent Audits
Five deeper problems we found across this year's audit dataset.
Jun 11
•
The FDA Group
10
1
House Appropriators Tell FDA to Accelerate its IND Sign-Off
Congress wants faster entry into early-phase trials as drug development keeps shifting toward China and Australia.
Jun 11
•
The FDA Group
7
1
6 Ways to Stay Ready for FDA Inspections
Readiness depends less on last-minute preparation and more on whether your quality system is clear, defensible, and easy to execute every day.
Jun 10
•
The FDA Group
8
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