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Consultant Spotlight: What a Career in 510(k)s Teaches You About Reading the FDA with Trey Thorsen, MS, RAC
How a chemistry major became a 510(k) specialist, and what he's learned about getting devices through the FDA.
20 hrs ago
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The FDA Group
7
1
12:24
7 More Takeaways From Our Q2 2026 Audit Data
We extract a few more important insights from our Q2 audit reports.
Jul 28
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The FDA Group
12
1
What Our Auditors Are Finding Lately: 7 Trends Across GMP, GLP, GCP, and Device Work (Q2 2026)
A quarter's worth of supplier qualifications, mock inspections, vendor re-quals, and internal audits, read back to back.
Jul 23
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The FDA Group
8
1
RA/QA News Roll: Mid July 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
Jul 21
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The FDA Group
5
1
Closing the DSCSA Investigation Gap
Suspect-product handling asks distribution and dispensing teams to run the kind of investigation a GMP quality unit runs every day. On that side of the…
Jul 20
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The FDA Group
5
1
Leading Through the AI Shift with ASQ's CEO Sid Bhatnagar
The head of the American Society for Quality on why AI is now a leadership problem, not a technology one, and what executives owe their people through…
Jul 14
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The FDA Group
7
49:13
Growing Your Career in RA/QA with Jessica Beaver
A conversation about the questions every regulatory and quality professional eventually has to answer for themselves.
Jul 10
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The FDA Group
2
53:41
Where Our Auditors Are Finding QMSR Compliance Gaps
The QMSR readiness work our teams are doing on client QMS projects keeps surfacing the same handful of exposures.
Jul 8
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The FDA Group
8
Leading Through the AI Shift with ASQ's CEO Sid Bhatnagar
A special one for us: we sat down with Sid Bhatnagar, CEO of ASQ, the American Society for Quality.
Jul 3
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The FDA Group
1
49:13
RA/QA News Roll: Late June 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
Jul 3
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The FDA Group
3
[June 2026] CMC Flexibility for Cell and Gene Therapy, Finalized Human Factors Submission Guidance + a Data Integrity Warning Letter
Watch now (50 mins) | The FDA loosens CMC requirements for cell and gene therapy products, publishes a yes/no flowchart that right-sizes human factors…
Jul 1
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The FDA Group
7
1
50:08
What Stuck With Us at DIA 2026
We went to Philly to give a talk and came home with a notebook full of everyone else's. Here are a few things we're still thinking about.
Jul 1
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The FDA Group
8
1
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