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Navigating Risk Management in Medical Devices with Brian Dense
Watch now (36 min) | The FDA Group's Nick Capman sits down with Brian Dense, a medical device consultant with over 30 years of experience, to discuss…
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The FDA Group
[May 2023: The Compliance Issue] Addressing the Top-Cited CFRs to Pharma and Device Firms + Warning Letter Breakdown
Watch now (47 min) | We take a close look at most frequently cited CFRs to drug and device firms throughout FY2022 and break down two recently issued…
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The FDA Group
April 2023
Introducing our Functional Service Program (FSP)
Watch now (2 min) | Bundle your RA/QA projects with The FDA Group for deep discounts.
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The FDA Group
[April 2023 Issue] FDA Finalizes Guidance on REMS Format and Content, Preparing for Expanded Device Inspection Authority + Warning Letter…
Watch now (50 min) | We explore FDA's expectations for the format and content of a REMS, how to prepare for more medical device inspection authority…
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The FDA Group
March 2023
RA/QA News Roll: March 2023
Here's what's happening at FDA and across the broader life science RA/QA space.
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The FDA Group
[Bonus Issue] Inside FDA's Pre-Approval Inspections with Former FDA Investigator, Christopher Smith
Watch now (51 min) | Former FDA Investigator, Christopher Smith shares his insights on FDA Pre-Approval Inspections (PAIs).
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The FDA Group
Implementing ICH Q14’s Enhanced Approach to Analytical Method Development, FDA's Proposed Framework for Human Factor Info in Device…
Watch now (46 min) | We explore FDA's new list of alternative ways to comply with cGMP requirements for combo products, dissect a new draft guidance for…
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The FDA Group
February 2023
[Bonus Issue] Top 5-Year Trending FDA GMP Inspection Citations (FY2018 to FY2022)
Wondering which GMP-related CFRs FDA is citing most frequently? Check out our interactive data visualizations and prioritize your compliance assurance…
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The FDA Group
Revised Compliance Guides for PAIs and GMP Drug Inspections, New Guidances On Device Post-Approval Studies, Postmarket Surveillance …
Watch now (46 min) | We explore FDA's new list of alternative ways to comply with cGMP requirements for combo products, dissect a new draft guidance for…
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The FDA Group
January 2023
The Insider Newsletter Mailbag
Have RA/QA/Clinical questions you'd like our experts to address in a future issue? Paid subscribers can submit questions at any time using our simple…
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The FDA Group
[Bonus Issue] Inspection-Related Policies in the Food and Drug Omnibus Reform Act
The new omnibus package includes a number of changes that expand FDA’s inspection authorities and reform the way FDA conducts inspections.
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The FDA Group
Alternative cGMP Compliance Methods for Combo Products, Device Production and Quality System Software Assurance + Warning Letter Breakdown
Watch now (46 min) | We explore FDA's new list of alternative ways to comply with cGMP requirements for combo products, dissect a new draft guidance for…
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The FDA Group
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