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| Articles by John Robinson |
221. Why is software validation necessary ?
May 09, 2013
About the Speaker Founder of Computer System Validation (CSV), David Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA and Computer System Validation. His latest book, Risk Based Software Validation –Ten easy Steps, relates to the development, purchase, installation, operation...
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222. BRC Risk Analysis
April 26, 2013
BRC Risk Analysis BRC risk analysis is about the guidelines issued by the international risk analysis body, the British Retail Consortium (BRC). Being a product of deliberations over a long period of time; BRC is today a global food safety standards body thatis hard onrisk analysis. This mak...
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223. Risk Management
April 01, 2013
Almost no business, whether it is a local grocer selling to a handful of customers or a multinational spread across the globe, is exempt from risk management. This should be one of the most used and most important terms in a business. There is every reason to believe that risk is as inherent to busi...
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224. Medical devices and the FDA
April 01, 2013
CLICK HERE">Medical devices constitute a very huge and complex field. Devices can range from anything between a thermometer and a pacemaker. The FDA, the US’ food and drug regulatory body, has a definition for devices. It considers a medical device as “an instrument, apparatus, implement, machin...
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225. Drugs and biologics
April 01, 2013
The efficacy of drugs vs. biologics is one of the hotly debated topics in the medical fraternity. Drugs and biologics are distinct and different from each other, but both are important components of the health industry.
How is a drug different from a biologic? Let us understand at th...
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226. SOX Compliance
April 01, 2013
SOX compliance is a major requirement for American corporate entities. SOX, or Sarbanes-Oxley Act, is a piece of legislation that is aimed at protecting investor interests and regulating corporate governance. It seeks to make American corporations such as public accounting firms and management and p...
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227. Pharmaceutical Compliance
March 07, 2013
An understanding of pharmaceutical compliance Pharmaceutical regulatory compliance, or just pharmaceutical compliance, is a critical area of pharmaceuticals. Why? This is because pharmaceutical science is very exact and extremely important for people's health. If there is noncompliance in t...
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228. Compliance Training Factors
March 07, 2013
Compliance training is an indispensable tool for organizations of any nature or size. Compliance training involves imparting skills and knowledge needed for the organization to be compliant with regulations. These regulations are set out by respective regulatory authorities, and organizations have t...
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229. Compliance Training
March 04, 2013
Understanding Compliance Training Almost every organization needs to comply with some or another regulation. There are countless regulations that organizations have to comply with. Many regulations are general in nature, some are specific to an industry, and others are specific to employee t...
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230. Regulatory Compliance ?
March 04, 2013
What is Regulatory Compliance? The best route to understanding what regulatory compliance means is to go the root of the expression, which is clear. Compliance is described as a state of being in accordance with set regulations. So, regulatory compliance is simple -it is being compliant with...
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Author: John Robinson
