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Guidance Breakdown: Providing Regulatory Submissions in Electronic Format — IND Safety Reports
Apr 5, 2024
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Guidance Breakdown: Providing Regulatory Submissions in Electronic Format — IND Safety Reports
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A Few Quick Tips for CAPA System Success in 2025
Jan 22
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A Few Quick Tips for CAPA System Success in 2025
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One of the Most Concerning Warning Letters We've Seen in a While
Dec 3, 2024
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One of the Most Concerning Warning Letters We've Seen in a While
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FDA Guidance Breakdown: Reformulating Drug Products That Contain Carbomers Manufactured With Benzene
Jan 4, 2024
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FDA Guidance Breakdown: Reformulating Drug Products That Contain Carbomers Manufactured With Benzene
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40:45
Mastering FDA and EMA Regulatory Meetings with Ashley Preston
An insider's guide to navigating critical regulatory meetings with FDA and EMA, from strategy and preparation to successful negotiations that advance…
20 hrs ago
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Mastering FDA and EMA Regulatory Meetings with Ashley Preston
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10 Overlooked Questions for Drug Manufacturing Inspection Readiness
A practical guide drawn from the FDA Compliance Manual, our audit experience, and common pitfalls that sink compliance efforts.
Feb 7
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10 Overlooked Questions for Drug Manufacturing Inspection Readiness
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How a Biotech Startup Filed 3 INDs in 1 Year Through Early Quality System Investment
A preclinical biotech company focusing on gene mutation-targeted therapies made an unconventional choice: investing in comprehensive quality systems…
Feb 6
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How a Biotech Startup Filed 3 INDs in 1 Year Through Early Quality System Investment
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Working with Chinese CROs: Benefits, Risks, and Best Practices with Harri Järveläinen
An insider's perspective on navigating Chinese CRO partnerships.
Feb 5
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Working with Chinese CROs: Benefits, Risks, and Best Practices with Harri Järveläinen
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38:08
5 Takeaways from the FDA's 2025 IT Operations Plan
The FDA's 2025-2027 tech roadmap signals major changes ahead for regulated industries. Here's what you need to know about submissions, AI, data…
Feb 5
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5 Takeaways from the FDA's 2025 IT Operations Plan
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RA/QA News Roll: Late January 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
Feb 4
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RA/QA News Roll: Late January 2025
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1:01:39
[January 2025] FDA Inspection Readiness, EtO Policy Changes + Warning Letter Analysis
Watch now (62 mins) | We open 2025 examining best practices for FDA inspection readiness and dissecting the agency's expedited pathway for EtO…
Feb 3
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[January 2025] FDA Inspection Readiness, EtO Policy Changes + Warning Letter Analysis
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46:45
Developing and Retaining an Engaged Workforce with Astellas Pharma's VP & Head of Quality Systems, Jill O'Mullane
A few actionable strategies for boosting employee engagement, development, and retention in 2025.
Jan 24
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Developing and Retaining an Engaged Workforce with Astellas Pharma's VP & Head of Quality Systems, Jill O'Mullane
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A Few Quick Tips for CAPA System Success in 2025
CAPA remains a top compliance concern year after year — one we see all the time in audits. Here are five practical steps you can take right now to…
Jan 22
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The FDA Group
11
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A Few Quick Tips for CAPA System Success in 2025
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When the QA Manager Leaves: A 5-Month Staff Augmentation Success Story
When a QA manager's sudden departure left critical systems in disarray, one experienced consultant stepped in to rebuild vendor management, implement…
Jan 21
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The FDA Group
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When the QA Manager Leaves: A 5-Month Staff Augmentation Success Story
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RA/QA News Roll: Mid January 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
Jan 16
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The FDA Group
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RA/QA News Roll: Mid January 2025
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The FDA Just Released a Ton of Guidance Documents
The agency is kicking off 2025 with a trove of new guidance just weeks before the new administration takes over. Here's a handy reference to what just…
Jan 7
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The FDA Just Released a Ton of Guidance Documents
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Guidance Breakdown: The FDA Updates its GUDID Final Guidance
The update makes minor revisions from the previous 2014 guidance, including the removal of now-unneeded FDA Preferred Terms or codes from the database…
Jan 3
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Guidance Breakdown: The FDA Updates its GUDID Final Guidance
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RA/QA News Rolls
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RA/QA News Roll: Late January 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
Feb 4
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The FDA Group
5
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RA/QA News Roll: Late January 2025
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RA/QA News Roll: Mid January 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
Jan 16
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The FDA Group
4
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RA/QA News Roll: Mid January 2025
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RA/QA News Roll: Late December 2024
Here's what's happening at FDA and across the broader life science RA/QA space.
Jan 2
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The FDA Group
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RA/QA News Roll: Late December 2024
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RA/QA News Roll: Mid December 2024 ❄️
Here's what's happening at FDA and across the broader life science RA/QA space.
Dec 17, 2024
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The FDA Group
3
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RA/QA News Roll: Mid December 2024 ❄️
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