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Aligning with Last Year's CSA Guidance: 10 Essential Questions for Device Firms
In January, we broke down FDA's new CSA draft guidance. Now we're focusing on the questions you can use to conduct a gap analysis.
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The FDA Group
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Warning Letter Breakdown: Poor Complaint Handling, Contamination Controls, and Minimizing Problems Tied to Defective Inhalers
Cipla received a warning letter listing ongoing issues with its Indian manufacturing facility. Earlier this year, the facility was the subject of a Form…
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The FDA Group
RA/QA News Roll: Late November 2023
Here's what's happening at FDA and across the broader life science RA/QA space.
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The FDA Group
[November 2023 Issue] FDA Issues Guidance on Post-Warning Letter Meetings, Urges Firms to Treat Device Risk Management File as a ‘Living…
Watch now (53 mins) | We dive into two significant FDA guidances and break down a warning letter citing numerous GMP deficiencies.
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The FDA Group
53:14
Catch Up With Our Recent Issues Over the Holiday
In case you have some time downtime, here's a handy list of links to everything we've published recently.
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The FDA Group
FDA Guidance Breakdown: Translating Non-English GLP Study Reports
A new draft guidance helps sponsors and nonclinical laboratories accurately translate study reports from non-English languages into English.
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The FDA Group
The Link Between Quality Culture and QA Communication Pathways with David Marks
This is a must-watch for any Quality leader looking for practical ways to bring a Quality culture to life.
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The FDA Group
1:08:52
A Few Thoughts on What FDA's OPQ Re-Org Could Mean for Industry
The FDA recently announced a reorganization of its OPQ that aims to correct inefficiencies in its operation worsened by the pandemic. Here's what teams…
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The FDA Group
The FDA Group's Insider Newsletter
The FDA Group's Insider Newsletter
The latest news and exclusive analysis across the FDA-regulated industries from former FDA professionals and industry experts. New issues every month. Save time gathering the critical industry intelligence you need to act on.
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