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RA/QA News Roll: Mid April 2024
Here's what's happening at FDA and across the broader life science RA/QA space.
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The FDA Group
Strategic Insights from Novartis's Front Lines: Leading Through Transition
Novartis's Global Program Clinical Head shares his experiences navigating the personal and professional challenges of a department shutdown, layoffs…
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The FDA Group
47:25
Guidance Breakdown: Providing Regulatory Submissions in Electronic Format — IND Safety Reports
A new final guidance mandates electronic submission of IND safety reports for serious and unexpected suspected adverse reactions, detailing technical…
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The FDA Group
RA/QA News Roll: Late March 2024
Here's what's happening at FDA and across the broader life science RA/QA space.
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The FDA Group
Real Talk on Remote Leadership with Nick Klingensmith
How to navigate the challenges of remote work, the disconnect between leadership, management, and frontline employees — and the effects on company…
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The FDA Group
44:47

March 2024

The Passionate Workforce: How to Create and Maintain Maximum Employee Engagement
The FDA Group's President and CEO, Nicholas Capman, introduces tactics and strategies to motivate your team and become the leader your employees need to…
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The FDA Group
The QMSR Explained: The Busy RA/QA Leader's Guide to Compliance Planning
Haven't had time to dive into the QMSR final rule? We did it for you. Here are the major points that impacted device firms will need to know and…
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The FDA Group
[March 2024] The 2024 Compliance Issue: Addressing the Top-Cited CFRs to Pharma and Device Firms + Warning Letter Breakdown
Watch now (91 mins) | We take a close look at most frequently cited CFRs to drug and device firms throughout FY2023 and break down a recent warning…
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The FDA Group
1:31:06
RA/QA News Roll: Mid March 2024
Here's what's happening at FDA and across the broader life science RA/QA space.
 • 
The FDA Group
How to Use Interim Consultants and Contractors Effectively in 2024
In light of layoffs across the industry, we're seeing more teams turn to cost-effective consultants and contractors to keep their projects on schedule…
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The FDA Group
5 Commonly-Overlooked Strategies for Supplier/Vendor Audits
Here are five strategies we find ourselves deploying most often when providing audit program support.
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The FDA Group
The FDA Proposes Several Changes to NDA and ANDA Forms
The proposed changes account for recent legislative requirements and allow for the submission of additional information.
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The FDA Group
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