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Putting in place a program for calibrating and maintaining test and measurement equipment is a regulatory requirement from both the FDA, under 21 CFR Part 210 and 211, and relevant EU regulations. Both these agencies have regulations that require this program from manufacturers.
The purpose of this equipment validation program is to ensure these…
Added by Compliance4all on May 26, 2017 at 6:21am — No Comments
Added by John Robinson on May 16, 2017 at 6:22am — No Comments
A perfect hire is a boon to any organization. At the other extreme, a bad hire can bring the inverse result to the organization: It can not only impede productivity; it can even result in drawing the organization into legal issues associated with wrong hiring. Problem employees create employee problems, which is why HR professionals need to be aware of what steps to take and what scenarios to avoid if…Continue
Added by John Robinson on May 5, 2017 at 6:21am — No Comments
Professionals in the field of statistical analysis need a clear and perceptive insight into how to understand and interpret statistical concepts used to investigate quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits. Along with these, process and quality controls, as well as ICH Q8 and Q9 also need to be properly and thoroughly understood.
The ICH tripartite-harmonized ICH…Continue
Added by John Robinson on May 3, 2017 at 6:18am — No Comments
In the area of GMP regulations, procedures are very vital, for both execution and audits. It is always true that the greater the clarity and comprehensiveness with which these procedures are written; the easier it becomes for users to use them without missing important information for regulators.
Despite the advent of technology into almost all the areas of GMP regulations; there is still the existence of the human factor. It is still the major…
Added by Compliance4all on April 19, 2017 at 6:44am — No Comments
Considered one of the most significant changes to be introduced into the American healthcare sector since the passage of the Affordable Care Act; the 21st Century Cures Act was one of the last legislative acts of outgoing president Barack Obama. Signed into law in December 2016; the 21st Century Cures Act seeks to strengthen medical research, foster innovation and accelerate the development of innovative treatments for chronic ailments such as cancer.…
Added by Compliance4all on March 16, 2017 at 6:00am — No Comments
The constant pressure on health services is an age old cliche, we need to constantly look at ways of improving the method of delivery with the growing demand of patients. We believe that everyone in the world should have access to safe, fast, affordable healthcare. Yet our healthcare services are falling short. Technology that connects patients with high quality care is part of the solution and we think we’re uniquely positioned to build it.
This correlates with the latest…Continue
Added by Dr Felix on March 13, 2016 at 8:18am — No Comments
Added by CC-Conrad Clyburn-MedForeSight on September 17, 2009 at 10:30am — No Comments
Added by Kelly Lewis on April 5, 2009 at 11:50pm — No Comments
Added by CC-Conrad Clyburn-MedForeSight on March 20, 2009 at 9:49pm — No Comments
Added by CC-Conrad Clyburn-MedForeSight on December 24, 2008 at 6:30am — No Comments
Added by CC-Conrad Clyburn-MedForeSight on December 2, 2008 at 4:30pm — No Comments
Added by Michael J. Russell on October 8, 2008 at 11:30am — No Comments
Added by CC-Conrad Clyburn-MedForeSight on July 9, 2008 at 9:00am — No Comments