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Blogs about: Gcp

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FDA Hits ICON with Warning Letter for J & J Studies1 comment

Carl's Blog on FDA Stuff wrote 1 week ago: FDA posted a new Warning Letter on its website to ICON Clinical Research, the CRO responsible for ma … more →

Tags: 1, Bioresearch Monitoring, Clinical Trials, Cro, FDA, fda warning letters

and now it's after gcp.

dilutedwater wrote 1 week ago: i’ve neglected this blog. i’ll admit it. i’m guilty. but now i’m going to ha … more →

Tags: School Life, Holiday, List

Added gaskets

elfringham wrote 1 month ago: 23rd November 2005 Today I received an email from GCP informing me that although my order total was … more →

Tags: Volvo, 1800's

Ordering issues

elfringham wrote 1 month ago: 21st November 2005 This morning I checked which wiper mechanism is installed which was Electrolux, a … more →

Tags: Volvo, 1800's, Windscreen Wipers, CVI, firefox

FDA Panel discusses "Artificial Pancreas" at Diabetes Technology Meeting

Carl's Blog on FDA Stuff wrote 1 month ago: The 9th Annual Diabetes Technology Meeting held 5-7 November 2009 in Burlingame, CA drew a number of … more →

Tags: 1, Clinical Trials, Diabetes Technology, FDA, Medical Device Safety, Public Health

SQA Abstract 2 - Building a Better Way

tjkuhn wrote 1 month ago: And here’s the second abstract I submitted. This one is with colleagues from Data Management a … more →

Tags: Data integrity, GxP, Pharmaceuticals, technology, Computer Validation, Data Management, eCRF, edc, electronic data capture

SQA Abstract - Impact of eSystems, etc.

tjkuhn wrote 1 month ago: I’ve submitted this abstract to the SQA for their annual meeting in April and am really hoping … more →

Tags: Data integrity, GxP, Pharma, Pharmaceuticals, qa, Quality Assurance, technology, Thought, tjkuhn

First Chinese Clinical Research Outsourcing Industry Standard Under Development

Albin Paul wrote 1 month ago: According to information from the The Contract Research Organization Union China (CROU) under the Ch … more →

Tags: microarray, China, Clinical Research, Clinical Research Organization, clinical trial, contract research organization, Cro, drug administration, ICH_GCP

gettingrac wrote 2 months ago: Getting RAC Certification MBA, MS (Biomedical Engineering) swaminathan_ss@yahoo.com OBJECTIVE Create … more →

Tags: Getting RAC, Ind, ide, 510k, E6, + Ich, Phase I, phase ii, phase iii

Fundamentals of Quality1 comment

tjkuhn wrote 2 months ago: I’ve gotten some questions of late that have had me thinking about the core of what I do; fund … more →

Tags: GxP, Health Care, Healthcare, Pharmaceuticals, qa, Quality Assurance, Thought, tjkuhn, Fundamentals

It's finally over2 comments

nuke wrote 2 months ago: The end of the road, the last hurrah. I read that Dan Rather’s lawsuit against CBS had been di … more →

Tags: MOONBATS, lgf, who is this nancy?, Chaz Johnson, Mike C

A New Article on FDA Clinical Trials 2 comments

Carl's Blog on FDA Stuff wrote 2 months ago: A new article published in the current issue of GxP Lifeline, a Master Control newsletter, explains … more →

Tags: 1, FDA Enforcement Issues, Bioresearch Monitoring, FDA Inspections, FDA, Clinical Trials, Quality Assurance, alpha inventions

GCP update25 comments

grouchyconservativepundit wrote 3 months ago: Watch the “Forum Comments” section to your immediate left. This is an RSS feed which wil … more →

Tags: grouch conservative pundits, grouchyconservativepundits.com, what happenned to GCP

The horse is in the barn. The el is in the bow.2 comments

grouchyconservativepundit wrote 3 months ago: *Sooper Seekrit translation: Dos attack at main forum server. Feel free to gather here or at Nano … more →

Tags: grouchyconservativepundits

FDA Sends J&J a Warning Letter for clinical trial failures as a sponsor 2 comments

Carl's Blog on FDA Stuff wrote 4 months ago: Johnson and Johnson received a Warning Letter from FDA for their failure to properly supervise clini … more →

Tags: 1, Bioresearch Monitoring, Clinical Trials, Drug safety, FDA, FDA Commissioner, FDA Enforcement Issues, FDA Inspections, fda warning letters

Another viewpoint on the post: A Question of Significance

Carl's Blog on FDA Stuff wrote 4 months ago: I received this comment on my post A Question of Significance (scroll down) from another clinical tr … more →

Tags: 1, FDA Enforcement Issues, Bioresearch Monitoring, FDA Inspections, FDA, monitoring clinical trials, Drug safety, Clinical Trials, Quality Assurance

looking forward to the day i can truly laugh at the whole situation4 comments

L wrote 4 months ago: A broken flat screen TV, 1 year of increased electricity bill (2x), my brand new couch used as a scr … more →

Tags: Roommate

FDA Changes Website for clinical trial information

Carl's Blog on FDA Stuff wrote 4 months ago: The FDA announced that it has changed its website and that links for GCP documents might no longer w … more →

Tags: 1, Clinical Trials, FDA, fda warning letters, FDA website, Food Safety, GLP, h1n1

Should ICH GCP be reviewed and revised?

Andrew Smith wrote 4 months ago: ICH guideline E6 (ICH-GCP) is, along with the Declaration of Helsinki, arguably the most important d … more →

Tags: Clinical Research, Clinical Research focus, Drug Development, Pharmaceutical Development, Quick Thoughts, Good Clinical Practice, ICH-GCP


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