How Redica Systems Goes Further than the FDA Data Dashboard

Redica Responds: What are Common Laboratory Inspection Findings?

Is Raw FDA Data Skewing Your Analyses?

Instant Download: Insights on Quality from FDA Leaders

PAIs and 483 Issuance Risk: The Trends Are Not What They Seem

Instant Download | Analysis of 2021 U.S. FDA 483 GMP Observations

Instant Download | Yes, Warehouses Must Comply with Relevant GMPs

Instant Download | FY2020 and FY2021 Drug GMP Warning Letter Analysis

Instant Download | Analysis of COVID-19 Vaccine and Drug 483s

How Small Pharma Firms Can Prepare for a GMP Inspection

Part II: An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report

Part I: An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report

FDA FY2020 Drug Inspection Observations and Trends

Data Integrity 101: Why is it Important?

Highlights from Recent FDA Inspections of Vendors/Suppliers

Hosting a Virtual FDA Inspection: Advice from Former FDA Investigator and Investigations Director Ricki Chase

Preparing for a Virtual FDA Inspection: Advice from Former FDA Investigator and Investigations Director Ricki Chase

A State-of-the-Art Virtual Inspection Methodology Using Mixed Reality Technology Gets High Marks from European Medicines Agency Inspector

David Doleski Encourages Industry to Participate in FDA’s Emerging Technology Efforts; Sanofi Case Study Reviewed

What is Risk-Based Thinking?

Part 2: Analysis of FDA FY2019 Drug GMP Warning Letters

Part 1: Analysis of FDA FY2019 Drug GMP Warning Letters

Did COVID-19 Kill Just-in-Time Pharma Supply Chains?

COVID-19 Pandemic and Your GMP Audit Schedule for 2020

Update: What are Pharma and Med Device Firms Doing About COVID-19?

The Importance of Monitoring Import Alerts

What All API Manufacturers Need to Know

Enforcement Actions Against Sartan Manufacturers

Part 2: How Amgen Uses AI Tools To Improve Manufacturing Deviation Investigations

Identification of Software Validation Shortcomings

Recent Statement Regarding ARB Recalls

AveXis’s New Gene Therapy Approved but New Questions Are Raised

MHRA’s “Right Environment”

Analysis of CDER Report on Pharmaceutical Quality

How Small Pharma Firms Can Prepare for a GMP Inspection in 2019

Data Integrity Trends in 483s and Warning Letters: Part 3

Data Integrity Trends in 483s and Warning Letters: Part 2

Data Integrity Trends in 483s and Warning Letters: Part 1

CDER Warning Letter Trends by Facility Type

Part 3: An Analysis of FDA FY2018 Drug GMP Warning Letters

Why Did McKesson Receive the First DSCSA Warning Letter?

FDA Form 483: The Ultimate Guide

FDA Cites Part 11 in Clinical Trial

FINAL Part 3: Who’s Who? Seeing CROs Clearly.

Part 2: Who’s Who? Seeing CROs Clearly.

Part 1: Who’s Who? Seeing CROs Clearly.

FINAL Part 2: How to Stop the Data Integrity Excuses

Part 1: How to Stop the Data Integrity Excuses