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