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insider.thefdagroup.comLatest Issues
7 Audit Program Planning Moves to Make in Q3
We recently published our comprehensive guide to annual audit planning. This is the compressed companion version: seven things to do this quarter to prep for next year if you haven’t solidified your plan yet.
As we noted in our other guide...
What Shaped You Isn't on Your Resume, with Jessica Smith, PhD
This is an episode of The Passionate Workforce Podcast. Subscribe on Apple Podcasts here and grab the bestselling book on Amazon. These conversations are also available on YouTube.
Jessica Smith has a PhD in bioengineering, 25 years in med...
FDA Warning Letter Breakdown: The Early QMSR Letters Keep Landing on Risk Management
Three letters, three Clause 7.1 citations, and three different ways to fail it. Here's what FDA actually cited, and what to check in your own system before your first QMSR inspection.
Only paid subscribers get regular full access to our wa...
Nice Is Not Always Kind: Emotional Safety in Small Companies with Nichole DiLoretta
This is an episode of The Passionate Workforce Podcast. Subscribe on Apple Podcasts here and grab the bestselling book on Amazon. These conversations are also available on YouTube.
Being “nice” can sometimes mean avoiding a conversation th...
Guidance Breakdown: FDA Finalizes Its Meeting Framework for OTC Monograph Drugs
A breakdown of CDER's July final guidance on formal meetings under section 505G. The disclosure rules are the part to read twice!
This guidance breakdown is available in full to paid subscribers. Only paid subscribers get regular full acce...
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