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[Bonus Issue] Inside FDA's New Draft Guidance on Using "Alternative Tools" for Manufacturing Inspections
The guidance outlines methods previously used by the agency during the pandemic to examine drug manufacturing facilities, back when FDA inspections…
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The FDA Group
How to Overcome 5 Common Challenges in Computer System Validation (CSV)
Watch now (55 mins) | A free webinar with senior validation engineer and The FDA Group consultant, Rashida Ray
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The FDA Group
RA/QA News Roll: Mid September 2023
Here's what's happening at FDA and across the broader life science RA/QA space.
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The FDA Group
August 2023
RA/QA News Roll: Late August 2023
Here's what's happening at FDA and across the broader life science RA/QA space.
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The FDA Group
[August 2023 Issue] AI and Machine Learning: FDA Spells Out Specifics for Manufacturing, Another Perspective on PCCPs for AI/ML Devices …
Watch now (66 mins) | We dive into FDA's recommendations for AI/ML in manufacturing, look again at PCCPs for AI/ML devices, and break down a Warning…
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The FDA Group
[Bonus Issue] Gap Analysis Remediation: A Guide to Resourcing and Implementation
Watch now (60 mins) | How to close gaps in life science quality management
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The FDA Group
RA/QA News Roll: Mid August 2023
Here's what's happening at FDA and across the broader life science RA/QA space.
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The FDA Group
July 2023
RA/QA News Roll: Late July 2023
Here's what's happening at FDA and across the broader life science RA/QA space.
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The FDA Group
The Critical Role of 'Hyper-Targeting' in Rare Disease Drug Development with Dan Donovan
Watch now (30 mins) | The FDA Group’s Nick Capman sits down with Dan Donovan, an expert in rare disease drug development, to explore the unique…
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The FDA Group
[July 2023 Issue] FDA's Draft Guidance on OTC Drug Submissions Content/Format, PCCPs for AI/ML Devices + Warning Letter Breakdown
Watch now (46 mins) | We dive into two recent draft guidances—the first for OTC drug firms and the second for device firms, then break down a Warning…
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The FDA Group
RA/QA News Roll: Mid July 2023
Here's what's happening at FDA and across the broader life science RA/QA space.
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The FDA Group
June 2023
RA/QA News Roll: Late June 2023
Here's what's happening at FDA and across the broader life science RA/QA space.
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The FDA Group
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