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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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FDA Uncovers Critical Manufacturing Violations at Chinese API Makers
Feb 13
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FDA Uncovers Critical Manufacturing Violations at Chinese API Makers
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Guidance Breakdown: Considerations for Complying With 21 CFR 211.110
Feb 12
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Guidance Breakdown: Considerations for Complying With 21 CFR 211.110
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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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RA/QA News Roll: Mid February 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
Feb 14
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The FDA Group
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RA/QA News Roll: Mid February 2025
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81 Days: Countdown to Stage 1 Compliance for the FDA's LDT Final Rule
A question for labs with LDTs on the market: are you ready?
Feb 14
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81 Days: Countdown to Stage 1 Compliance for the FDA's LDT Final Rule
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Clinical Outsourcing & Insourcing: Selecting the Right Model or Mix with Mark Shapiro
An insider's perspective on navigating CROs, FSPs, contractors, and FTEs in modern drug development.
Feb 13
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Clinical Outsourcing & Insourcing: Selecting the Right Model or Mix with Mark Shapiro
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32:57
FDA Uncovers Critical Manufacturing Violations at Chinese API Makers
The FDA put two Chinese API makers on import alert after failed inspections.
Feb 13
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The FDA Group
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FDA Uncovers Critical Manufacturing Violations at Chinese API Makers
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Guidance Breakdown: Considerations for Complying With 21 CFR 211.110
A new draft guidance describes how to comply with the requirements in 21 CFR 211.110 to ensure batch uniformity and drug product integrity.
Feb 12
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Guidance Breakdown: Considerations for Complying With 21 CFR 211.110
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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…
Feb 10
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The FDA Group
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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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38:08
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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The FDA Group
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Working with Chinese CROs: Benefits, Risks, and Best Practices with Harri Järveläinen
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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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The FDA Group
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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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The FDA Group
5
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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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The FDA Group
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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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The FDA Group
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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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RA/QA News Rolls
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RA/QA News Roll: Mid February 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
Feb 14
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The FDA Group
11
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RA/QA News Roll: Mid February 2025
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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
5
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RA/QA News Roll: Late December 2024
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