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5 Simple (But Often Overlooked) Best Practices for Annual Audit Planning
A few practical tips for Quality leaders preparing to host auditors.
8 hrs ago
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The FDA Group
The End-of-Year Quality Crunch: 5 Projects Demanding Extra Hands in Q4
What we’re seeing inside QA teams across the industry, and how flexible staff augmentation helps them finish the year strong.
Oct 29
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The FDA Group
1
Guidance Breakdown: QMS Information for Certain Premarket Submission Reviews
What device firms need to include (and update) before February 2026 to keep their PMAs and HDEs moving under the new QMSR framework.
Oct 29
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The FDA Group
RA/QA News Roll: Mid October 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
Oct 17
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The FDA Group
A Pressure-Tested Playbook for FDA Inspections and Remediation with Jeff Hines
Coruna Medical's Vice President of Quality shares his 4-room inspection model and how to lead through remediation with composure, clarity, and…
Oct 17
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The FDA Group
1
52:24
What FDA’s Latest OTC Warning Letters Say About Common Failure Modes (And How to Close Them)
Three FDA warning letters posted on October 7 highlight recurring OTC gaps.
Oct 14
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The FDA Group
2
A Case Study in FDA Warning Letter Response and Quality System Overhaul
After an inspection revealed wide-ranging cGMP gaps, an OTC topical firm rebuilt its quality systems from the ground up.
Oct 8
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The FDA Group
2
FDA Warning Letter Breakdown: Data Integrity and Investigation Discipline Issues at a California OTC Drug Firm
Why CDER cited QU authority gaps, investigation shortfalls, and reformulation without validation—and what similar firms should do next.
Oct 7
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The FDA Group
5
How the Shutdown is Affecting the FDA
Another shutdown leaves the FDA balancing public health responsibilities against frozen funding. Here’s what continues, what stops, and what it means…
Oct 6
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The FDA Group
2
Leading Cross-Functional Teams from Concept to Commercialization with Marwan Fathallah
DIA Global’s CEO shares how leaders can balance innovation, rigor, and collaboration across R&D, regulatory, and commercial functions to deliver quality…
Oct 6
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The FDA Group
1
1
46:19
RA/QA News Roll: Late September 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
Oct 6
•
The FDA Group
1
September 2025
Breaking Down E21: Including Pregnant & Breastfeeding Women in Clinical Trials with Regina Atim
How FDA/ICH’s draft E21 guidance shifts sponsors from default exclusion to risk-based inclusion—and what to do next.
Sep 30
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The FDA Group
4
28:35
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