Blogs about: 21 Cfr

Featured Blog

21 CFR (Part 820)

mentorhealth wrote 3 weeks ago: 21 CFR (Part 820) is one of the prime FDA regulations dealing with Quality System Regulation (QSR). … more →

Tags: Hospital Management, clinical informatics, Medical Update, 21 CFR Part 820, FDA regulations, Quality System Regulation, QSR

What are Design History File Requirements?

globalcompliancepaneltraining wrote 7 months ago: What are Design History File Requirements? The Design History File (DHF) is a critical document for … more →

Tags: Healthcare, Pharma, Medial, Medical device, Design history file, DHF, DHF requirements

Read This If You Manufacture Medical Devices1 comment

Rachel Agheyisi wrote 12 months ago: If you’ve read some of the other articles posted here, you’re probably aware that the U.S. Food and … more →

Tags: Enforcement Updates, FDA, fda warning letters, Medical Devices, current good manufacturing practices, Food and Drug Administration, FDA Warning Letter, Premarket Approval

Compliance Online Training

macthp25 wrote 1 year ago: Compliance Online Training Get trained on regulations affecting your industry through online webinar … more →

Tags: compliance online, compliance training, compliance.com, FDA Compliance, FDA, Medical Devices, GMP, GLP, cGMP

CHINESE API MANUFACTURING FACILITIES RECEIVE WARNING LETTER (MARCH 30, 2011)

Barry A. Friedman, PhD LLC wrote 2 years ago: NINGBO SMART PHARMACEUTICAL RELEASE WITH INCOMPLETE C of As Comment The Ningbo Smart Pharmaceutical … more →

Tags: FDA Compliance, warning letters., warning letter, FDA, FDA Guidance for Industry, Phase 1, API, OVI, Data integrity

CFR Corporate Members Get Lion

amysmartfree wrote 4 years ago: … more →

Tags: CFR, cfr cluj, 29 cfr, 49 CFR, cfr title, cfr part 11, 21 CFR Part 11, cfr regulation, 40 cfr

21 CFR part 11 Update2 comments

tjkuhn wrote 4 years ago: Folks, it looks like some of our US regulations and guidance documents have been flagged for update … more →

Tags: Pharma, technology, GxP, GCP, GMP, cGMP, GLP, Pharmaceuticals, tjkuhn


Related Tags
All →

Follow this tag via RSS