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The FDA grants marketing approval for certain types of medical products whose application is the result of foreign clinical studies, provided the products and the clinical studies meet certain conditions. The types of medical products…
Added by John Robinson on December 11, 2017 at 5:41am — No Comments
Statistics is extremely useful as a decision-making tool in the clinical research arena. In areas such as working in a field where a p-value can determine the next steps on development of a drug or procedure, it is very handy, because of which it is imperative for decision makers to understand the theory and application of…
Added by John Robinson on November 13, 2017 at 5:44am — No Comments
Geology is among the many branches of science in which compositional data (CoDa) arise naturally. In branches such as geochemistry, compositional data seem to occur typically, when one normalizes raw data or when one obtains the output from a constrained estimation procedure, such as percentages, ppm, ppb, molar concentrations,…
Added by Adam Fleming on October 27, 2017 at 6:07am — No Comments
Some of the functions of medical device manufacturers include:
o Analyzing complaints
o Processing data
o Evaluating nonconformances
o Utilizing other quality data sources.
The main purpose of this analysis, done using appropriate statistical methodology, under §820.100, is to identify the cause of nonconforming products and other quality problems. Time series analysis is one such family of these tools. Also called trending analysis,…
Added by Adam Fleming on September 18, 2017 at 6:49am — No Comments
The General Data Protection Regulation (GDPR), which has been codified as Regulation (EU) 2016/679, is a very powerful law regarding the protection of data of the half billion people who live in the European Union (EU). Having come into effect as a result of the European Commission having adapted the proposal for its creation on January 25, 2012; it will replace Directive…
ContinueAdded by Adam Fleming on August 16, 2017 at 5:32am — No Comments
The FDA’s regulations on cleanroom environmental monitoring (EM) are based on the assumption that any person who enters a cleanroom is likely and almost certain to have brought contaminants in one or another form with him. The FDA’s regulations on cleanroom environmental monitoring are built on the thinking that microorganisms can assail even the cleanest of systems, which is why its regulations on cleanroom…
ContinueAdded by Adam Fleming on August 9, 2017 at 5:39am — No Comments
Mastering MS Excel formulas and functions can make a miracle out of this program. When used optimally, MS Excel can be a wonderful tool for carrying out umpteen functions and optimizing work related to a number of departments. For example, the Accounts Department can do a number of important functions such as loan repayment calculation, generating a profit and loss statement, solve complex mathematical and engineering problems, and carry out anything that involves addition, subtraction,…
ContinueAdded by Adam Fleming on August 2, 2017 at 5:35am — No Comments
It is said that a picture is worth a thousand words. This adage may appear figurative and allegorical when applied to the realm of statistics, but there is no denying the fact that a visual approach to statistics enlivens the subject like no other. A dash of pictorial work and some coloring at the right places enhance the…
ContinueAdded by John Robinson on August 1, 2017 at 6:03am — No Comments
Added by John Robinson on June 5, 2017 at 7:26am — No Comments
The phrase “data integrity” seems to be everywhere. It is used in a number of places and situations, and the FDA has its own definition of the term. At its plainest, data integrity is defined as the assurance that data is complete, consistent and accurate. FDA requires this data to be…
ContinueAdded by John Robinson on May 3, 2017 at 5:29am — No Comments
Added by John Robinson on April 17, 2017 at 5:49am — No Comments
Our world today is unthinkable without data. We seem to be flooded by it. Day in and day out, the world processes trillions of bytes. Big Data seems to be everywhere and has compounded our already heavy reliance on data.
But has this proliferation of data made any significant difference to our lives? Has it made our business decision-making any more effective or insightful?…
Added by Adam Fleming on November 10, 2016 at 4:23am — No Comments
Going beyond just asking the laboratory for geochemical extracting information of a gold test by sampling every meter of the drill core of a trench and using multielement analysis is an approach strongly recommended by most mining specialists. There exist other methods of geochemical data analysis techniques and obtaining geochemical extracting information, but these are largely ignored by the industry.
Making sense of the geochemical extracting…
Added by Adam Fleming on October 27, 2016 at 5:50am — No Comments
If there is one common cause for apprehension between the smallest and biggest, and the best known and least known organizations; it has to be an FDA inspection! Any organization that is subject to an FDA inspection has to get absolutely everything of everything about its activities right to a T, to such an extent that it should be sure simply all the time, through all its processes, that an FDA inspection is not going to invite an FDA action such as a 483…
Added by Adam Fleming on June 2, 2016 at 3:08am — No Comments
Added by Stephen C Schimpff on July 16, 2009 at 10:13am — No Comments
Added by Clymer/JR on April 20, 2009 at 10:18am — No Comments
Added by Clymer/JR on February 11, 2009 at 10:00am — No Comments
Added by CC-Conrad Clyburn-MedForeSight on December 2, 2008 at 6:00pm — No Comments
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