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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…
Mar 26
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The FDA Group
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The Passionate Workforce: How to Create and Maintain Maximum Employee Engagement
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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…
Mar 21
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The QMSR Explained: The Busy RA/QA Leader's Guide to Compliance Planning
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[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…
Mar 19
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The FDA Group
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[March 2024] The 2024 Compliance Issue: Addressing the Top-Cited CFRs to Pharma and Device Firms + Warning Letter Breakdown
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RA/QA News Roll: Mid March 2024
Here's what's happening at FDA and across the broader life science RA/QA space.
Mar 15
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RA/QA News Roll: Mid March 2024
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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…
Mar 11
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How to Use Interim Consultants and Contractors Effectively in 2024
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5 Commonly-Overlooked Strategies for Supplier/Vendor Audits
Here are five strategies we find ourselves deploying most often when providing audit program support.
Mar 6
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The FDA Group
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5 Commonly-Overlooked Strategies for Supplier/Vendor Audits
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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.
Mar 6
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The FDA Group
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The FDA Proposes Several Changes to NDA and ANDA Forms
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FDA Guidance Breakdown: Key Information and Facilitating Understanding in Informed Consent
A new draft guidance provides recommendations related to two provisions of the revised Federal Policy for the Protection of Human Subjects by HHS and…
Mar 5
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FDA Guidance Breakdown: Key Information and Facilitating Understanding in Informed Consent
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February 2024
RA/QA News Roll: Late February 2024
Here's what's happening at FDA and across the broader life science RA/QA space.
Feb 29
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The FDA Group
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RA/QA News Roll: Late February 2024
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The FDA is Ramping Up Manufacturing Inspections in India
On the heels of a congressional grilling, the FDA is increasing inspections of Indian drug facilities due to supply and quality concerns.
Feb 28
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The FDA Group
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The FDA is Ramping Up Manufacturing Inspections in India
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10 Things You Should Be Doing to Verify Your Testing Labs' Data
How strong is your independent data verification program?
Feb 22
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The FDA Group
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10 Things You Should Be Doing to Verify Your Testing Labs' Data
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FDA Guidance Breakdown: Select Updates for the Medical Device User Fee Small Business Qualification and Certification
The FDA has published an updated guidance on the medical device user fees small businesses must pay, and the circumstances in which they may be exempt…
Feb 21
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The FDA Group
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FDA Guidance Breakdown: Select Updates for the Medical Device User Fee Small Business Qualification and Certification
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