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Navigating Supplier Audits in Japan with Derek Wessman
A few notes from the field on bridging the gap between Western expectations and Eastern practices.
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The FDA Group
27:40
RA/QA News Roll: Mid October 2024
Here's what's happening at FDA and across the broader life science RA/QA space.
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The FDA Group
Guidance Breakdown: Electronic Systems, Records, and Signatures in Clinical Investigations — 29 Q&As
The FDA finalized a guidance to help sponsors and clinical investigators comply with electronic records regulations for clinical trials under 21 CFR…
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The FDA Group
Inside FDA Pre-Approval Inspections with Former Investigator, Chris Smith
A former FDA Investigator shares his insights on FDA PAIs and how to prepare for them.
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The FDA Group
50:45
Guidance Breakdown: Our Top 10 Takeaways from the FDA's Guidance on Conducting Decentralized Trials
The FDA’s final guidance on DCTs adds clarity on HCP task log, inspection requirements, and data variability. We break it down.
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The FDA Group
RA/QA News Roll: Late September 2024
Here's what's happening at FDA and across the broader life science RA/QA space.
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The FDA Group

September 2024

Answering a Few FAQs About Navigating the 510(k) Process
A conversation with Trey Thorsen, MS, RAC, a veteran device consultant with many premarket notification submissions under his belt.
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The FDA Group
22:32
The Anatomy of an Effective Supplier Audit Report
We break down our own supplier audit template.
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The FDA Group
RA/QA News Roll: Mid September 2024
Here's what's happening at FDA and across the broader life science RA/QA space.
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The FDA Group
[September 2024] How to Build a Robust Audit Program, a Roadmap to Stage 1 LDT Compliance + Warning Letter Breakdown
We lay out the ingredients of a successful audit program, show LDT firms the way to compliance in time for the Stage 1 deadline in 2025, and break down…
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The FDA Group
33:41
Guidance Breakdown: FDA Revises Its 2018 Guidance on Submitting Amendments to ANDAs
A newly revised guidance updates a previous version and includes some major changes. We break it down.
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The FDA Group
CDER Chief on Inspection Backlog: 2025 Will Be a 'Crucial Year'
FDA's CDER director Patrizia Cavazzoni on Monday stressed that the agency will be ramping up its inspections in 2025 to reduce its pandemic backlog.
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The FDA Group
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