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5 GMP Audit Questions That Keep Catching Pharma Teams Off Guard

Jun 26, 2025 • The FDA Group

What Our Auditors Are Finding Lately: 8 Trends Across GMP and GCP Audits (Q2 2025)

Sep 10, 2025 • The FDA Group

A Few Quick Tips for CAPA System Success in 2025

Jan 22, 2025 • The FDA Group

FDA Uncovers Critical Manufacturing Violations at Chinese API Makers

Feb 13, 2025 • The FDA Group

29:09

Consultant Spotlight: What 30+ Years of FDA, Consent Decree, and GMP Work Teaches You About Fixing Real Quality Problems

A conversation with one of our senior consultants, Neal Siegel, PhD, on system-level thinking, consent decree lessons, and what experienced quality…

Jan 20 • The FDA Group

RA/QA News Roll: Mid January 2026

Here's what's happening at FDA and across the broader life science RA/QA space.

Jan 15 • The FDA Group

We Attended FDA’s QMSR Town Hall — Here’s What Device Firms Need to Know

We attended FDA’s QMSR town hall to hear directly how risk and design controls will be evaluated.

Jan 15 • The FDA Group

10 Last-Minute Questions for QMSR Compliance

We're less than a month away from the QMSR. Are you ready?

Jan 14 • The FDA Group

Building Phase-Appropriate Quality from Preclinical to Commercial with Jackie Klecker

How disciplined knowledge transfer, risk management, and communication prevent costly delays as products scale.

Jan 12 • The FDA Group

35:24

Guidance Breakdown: Processes and Practices Applicable to Bioresearch Monitoring (BIMO) Inspections

What sponsors, CROs, investigators, IRBs, and nonclinical labs need to know about how FDA conducts BIMO inspections, and how to prepare for them.

Jan 9 • The FDA Group

FDA Drug Reviews Held Steady in 2025 Despite Historic Staffing Losses

A new data study reveals what we've seen firsthand: the FDA isn't slowing down reviews even after trimming its staff significantly.

Jan 8 • The FDA Group

42:34

Preparing the Workforce That Will Shape Pharma’s Future with ISPE President & CEO Mike Martin

ISPE’s Mike Martin shares how automation, culture, and lifelong learning are redefining what it means to work in pharma.

Jan 6 • The FDA Group

FDA Warning Letter Breakdown: Complaint Backlogs, CAPA Blind Spots, and Risk Management Gaps at an Implantable Device Manufacturer

How unresolved quality system fundamentals cascade across complaints, CAPA, and design risk.

Dec 19, 2025 • The FDA Group

RA/QA News Roll: Mid December 2025

Here's what's happening at FDA and across the broader life science RA/QA space.

Dec 17, 2025 • The FDA Group

FDA Removes a Major Barrier to Using Real-World Evidence in Regulatory Reviews

The agency says it will now evaluate real-world evidence on a case-by-case basis, removing long-standing requirements for identifiable patient-level…

Dec 16, 2025 • The FDA Group

4 Drug GMP Takeaways From FDA's 2025 Warning Letters

And how QA teams should operationalize the data to strengthen compliance now.

Dec 15, 2025 • The FDA Group

FDA Issues Technical Amendments to Align Device Regulations With the New QMSR, Effective February 2, 2026

Regulatory housekeeping with strategic implications: the FDA just updated 179 sections across 21 CFR to reflect the QMSR shift. February 2026 isn’t far!

Dec 10, 2025 • The FDA Group

RA/QA News Rolls

RA/QA News Roll: Mid January 2026

Here's what's happening at FDA and across the broader life science RA/QA space.

Jan 15 • The FDA Group

RA/QA News Roll: Mid December 2025

Here's what's happening at FDA and across the broader life science RA/QA space.

Dec 17, 2025 • The FDA Group

RA/QA News Roll: Late November 2025

Here's what's happening at FDA and across the broader life science RA/QA space.

Dec 1, 2025 • The FDA Group

RA/QA News Roll: Mid November 2025

Here's what's happening at FDA and across the broader life science RA/QA space.

Nov 17, 2025 • The FDA Group

FDA News

FDA Drug Reviews Held Steady in 2025 Despite Historic Staffing Losses

A new data study reveals what we've seen firsthand: the FDA isn't slowing down reviews even after trimming its staff significantly.

Jan 8 • The FDA Group

FDA Removes a Major Barrier to Using Real-World Evidence in Regulatory Reviews

The agency says it will now evaluate real-world evidence on a case-by-case basis, removing long-standing requirements for identifiable patient-level…

Dec 16, 2025 • The FDA Group

4 Drug GMP Takeaways From FDA's 2025 Warning Letters

And how QA teams should operationalize the data to strengthen compliance now.

Dec 15, 2025 • The FDA Group

CDER Warning Letters Jump 50% in FY 2025 — What That Means for Industry

FDA enforcement is accelerating. The latest data shows where the agency is focusing and what companies should be preparing for now.

Dec 9, 2025 • The FDA Group

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