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Apr 14 2011
FDA opts for “effective remedy” with Triad
Apr 29 2019
Damage Control! How to Handle an FDA Drug or Device Recall – June 12, 2 PM EDT – Moore
Apr 22 2019
GotoWebinar: Verification and Validation Planning and Execution – July 24, 1 PM EDT – Lincoln
Apr 22 2019
GotoWebinar: Bullet-Proof Closed-Loop CAPA, Failure Investigation, and Root Cause Analysis – June 5 – Lincoln
Apr 22 2019
GotoWebinar: CGMP’s DHF, DMR, DHR, and EU’s Technical Documentation – June 11, 2019, 1 PM EDT – Lincoln
Apr 14 2019
How Pharmaceutical Packaging Can Lead to Product Recalls
Apr 12 2019
Canada Has Completed Its Transition to MDSAP
Apr 12 2019
FDA Audit Shows Data Manipulation at Immunonedics Plant
Apr 11 2019
Why Do You Need a Quality Agreement?
Apr 10 2019
How To Survive Your Next FDA Inspection – Survival Guide Tips and Techniques, June 11, 2019, 2 PM EST | Moore
Apr 10 2019
You Can’t Change That: FDA Reiterates Risk of Delegating Responsibility in Quality Agreements
Apr 10 2019
You Can’t Pass the Regulatory Compliance Buck with a Quality Agreement; FDA Reiterates the Point in a Recent Warning Letter
Apr 10 2019
Anyone Can Enter Into a Quality Agreement, It’s the Hold: FDA Issues a Warning Letter Referencing Lack of Quality Oversight
Apr 6 2019
FDA Essential: A Strong cGMP Quality Agreement| June 24, 2019, MINSK
Mar 22 2019
FDA Recall Chief Update – How to Design a Bulletproof Product Recall Strategy | June 6, 2019, 2 PM EDT | Hoffman
Oct 23 2018
Federal Judge Issues Consent Decree for OTC Tennessee Drug Manufacturer
Oct 23 2018
Catalent Fixes 483 Citations at Bloomington, Indiana Plant
Oct 23 2018
FDA Corrects Import Ban for Embattled Valsartan Maker
Oct 23 2018
FDA Doubts McKesson’s Abilities to Detect Illegitimate Drug Products
Oct 11 2018
How to Fail an FDA Medical Device Inspection in 3 Easy Steps!
Oct 2 2018
What You Should Expect in GMP Quality Agreements
Oct 2 2018
Don’t Be Haunted By Your Words in Documents
Oct 1 2018
DEA Moves Cannibidiol to Schedule V of the Controlled Substances Act
Oct 1 2018
Tips for Implementing a Root Cause Failure Analysis Program
Sep 29 2018
FDA Approval of Cannabis-Based Drug Will Lead to More Medications
Sep 28 2018
Top 10 Reasons Deviation Investigation Systems Fail
Sep 27 2018
Estabilishing a Legal Cannabis Business – What To Know
Sep 26 2018
Using Root Cause Analysis to Find Pharmaceutical Manufacturing Deviations
Sep 25 2018
How to Design an Effective CAPA Program, and Avoid FDA Scrutiny| June 5 – Lincoln
Sep 22 2018
Overview of High-Quality Cannabis Processing
Sep 21 2018
FDA Takes Regulatory Action Against 21 Websites Selling Unapproved Opioids
Sep 20 2018
FDA Plans to Revisit PMTA Process in 2018 and 2019
Sep 18 2018
Avoid FDA 483 Observations Through Effective Investigation and CAPA Procedures |
Sep 18 2018
FDA’a Regulatory Dilemma on e-Cigarettes
Sep 17 2018
Sun Pharma Plant in India Hit with FDA 483
Sep 16 2018
FDA Makes Clarifications About Making Inspection Results More Visible to Public
Sep 15 2018
FDA Provides Update on Risk-Based Drug Inspections
Aug 21 2018
Effective Laboratory Controls – How To Prepare for a System-Based FDA Audit | November 2, 2018, 2 PM EDT | Lanese
Aug 18 2018
The Hitchhiker’s Guide to 483s and Warning Letters – Oct. 20, 2018
Jul 18 2018
Regulatory Oversight in Drug Compounding on the Rise
Sep 16 2015
Indian Company Pan Drugs Redoing API Program After FDA Warning Letter
Jan 1 2015
Canada Hits Dr. Reddy’s With Import Ban
Dec 27 2014
Impax Hit With Another FDA 483
Dec 26 2014
FDA Making Changes to Drug and Manufacturing Oversight
Dec 26 2014
FDA Studies Drug Inspections Using Drone Technology
Jun 12 2014
FDA Warning Letter Hits Sun Pharma for Hiding Batch Failures
Jun 10 2014
FDA Slams US Wockhardt Plant With 483
Jun 10 2014
FDA Hits Wockhardt US Plant for Using Same Bad Tests as In India
Jun 10 2014
The Hitchhiker’s Guide to 483s and Warning Letters – FDA Compliance Trends, Response and Prevention |Oct. 15, 2015, 1 PM EDT | Bazigos
Jun 2 2014
FDA Must Act on Sunscreen Ingredients
Jun 2 2014
FDA Warning Slapped on Sun Lamps and Tanning Beds
May 29 2014
FDA OK’s Drugs That Boost Heart and Stroke Risks?
May 29 2014
Hamburg: Drugs Can Get to Patients Faster and Cheaper
May 27 2014
Sun Pharma Ripped by FDA in Warning Letter
May 27 2014
FDA Goes After Illegal Online Pharmacies Around the Globe
May 27 2014
FDA Inspected Wockhardt US Unit in March
May 22 2014
FDA Planning Label Update for Dozens of Drugs
May 21 2014
US Marshals Seize $11 Million in Drugs from Ascend Labs
May 21 2014
How Safe Are Drugs Made in India?
May 13 2014
Top Compliance Trends for 483s and Warning Letters for 2014 | Jan. 15 2015, 2 PM EST| Moore
May 7 2014
FDA Now Regulating E-Cigs

Upcoming Events

Damage Control! How to Handle an FDA Drug or Device Recall – June 12, 2 PM EDT – Moore →

In June, you have the unique opportunity to learn about how to avoid and manage FDA recalls from Dennis Moore,… Read more… →
GotoWebinar: Verification and Validation Planning and Execution – July 24, 1 PM EDT – Lincoln →

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of… Read more… →
GotoWebinar: Bullet-Proof Closed-Loop CAPA, Failure Investigation, and Root Cause Analysis – June 5 – Lincoln →

A company's CAPA System is supposed to be a major tool in resolving product complaint, non-conformance, and focusing OOS failure… Read more… →