Trends & Analysis Posts
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