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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
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
Inside FDA Pre-Approval Inspections with Former Investigator, Chris Smith
What PAIs actually check, why your investigations are probably written for the wrong audience, and why fear of an inspection usually points to a…
Jun 1
•
The FDA Group
8
2
50:45
TerSera's VP of Quality on the Audit Risk Hiding Inside Your Own Procedures
Your quality system looks great on paper. Can your team actually defend it?
May 18
•
The FDA Group
5
1
30:38
What Keeps Good Companies From Becoming Great?
Peter Martino on vision, focus, and the discipline of doing less.
May 2
•
The FDA Group
4
28:53
What Auditors Are Actually Looking For — And the Psychology Behind How They Find It
A lead auditor's perspective on why logistics matter more than most companies think, how to handle the silence trick, and what it takes to make audit…
Apr 28
•
The FDA Group
10
1
19:30
Why Kidney Disease Innovation Is a Tale of Two Cities — and What It Would Take to Change That with John Butler
Akebia's CEO on the regulatory clarity fueling rare kidney disease investment, the reimbursement structure starving dialysis of innovation, and the…
Apr 10
•
The FDA Group
8
1
35:12
Syncing Global Regulatory Filings Across FDA, EMA, and PMDA with AJ Acker
What it takes to align three major regulators on a single development program, and why treating ICH compliance as hard regulatory alignment is a…
Mar 30
•
The FDA Group
3
1
28:53
Navigating Regulatory Leadership Across Large and Small Life Science with Tammy Sarnelli
What changes (and what doesn't) when regulatory leaders move between structured enterprises and resource-constrained startups.
Mar 19
•
The FDA Group
1
1
32:46
Getting Data Governance for Regulatory Submissions Right Before AI Gets it Wrong with Cary Smithson
How life science companies can better govern their data to meet structured submission requirements, minimize regulator questions, and unlock the real…
Mar 5
•
The FDA Group
4
1
28:05
Building Resilient Biotech Teams in Cell and Gene Therapy with Nelly Viseux
A few lessons on adaptability, intentional innovation, and empowering teams to navigate scientific uncertainty.
Feb 10
•
The FDA Group
3
1
37:59
Consultant Spotlight: What 30+ Years of FDA, Consent Decree, and GMP Work Teaches You About Fixing Real Quality Problems
A conversation with one of our senior consultants, Neal Siegel, PhD, on system-level thinking, consent decree lessons, and what experienced quality…
Jan 20
•
The FDA Group
8
1
29:09
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