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[Bonus Issue] Inside FDA's New Draft Guidance on Using "Alternative Tools" for Manufacturing Inspections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…
Sep 22
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The FDA Group
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[Bonus Issue] Inside FDA's New Draft Guidance on Using "Alternative Tools" for Manufacturing Inspections
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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
Sep 20
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The FDA Group
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How to Overcome 5 Common Challenges in Computer System Validation (CSV)
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RA/QA News Roll: Mid September 2023
Here's what's happening at FDA and across the broader life science RA/QA space.
Sep 15
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The FDA Group
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RA/QA News Roll: Mid September 2023
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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.
Aug 31
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The FDA Group
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RA/QA News Roll: Late August 2023
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[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…
Aug 29
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The FDA Group
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[August 2023 Issue] AI and Machine Learning: FDA Spells Out Specifics for Manufacturing, Another Perspective on PCCPs for AI/ML Devices + Warning Letter Breakdown
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[Bonus Issue] Gap Analysis Remediation: A Guide to Resourcing and Implementation
Watch now (60 mins) | How to close gaps in life science quality management
Aug 22
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The FDA Group
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[Bonus Issue] Gap Analysis Remediation: A Guide to Resourcing and Implementation
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RA/QA News Roll: Mid August 2023
Here's what's happening at FDA and across the broader life science RA/QA space.
Aug 15
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The FDA Group
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RA/QA News Roll: Mid August 2023
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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.
Jul 28
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The FDA Group
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RA/QA News Roll: Late July 2023
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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…
Jul 25
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The FDA Group
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The Critical Role of 'Hyper-Targeting' in Rare Disease Drug Development with Dan Donovan
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[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…
Jul 21
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The FDA Group
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[July 2023 Issue] FDA's Draft Guidance on OTC Drug Submissions Content/Format, PCCPs for AI/ML Devices + Warning Letter Breakdown
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RA/QA News Roll: Mid July 2023
Here's what's happening at FDA and across the broader life science RA/QA space.
Jul 17
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The FDA Group
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RA/QA News Roll: Mid July 2023
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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.
Jun 29
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The FDA Group
3
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RA/QA News Roll: Late June 2023
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