All Blog Posts Tagged 'is' (30)

Continue

Continue

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

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…

Continue

Continue

After carrying out the initial preclinical studies, drug manufacturers need to implement cGMP quality systems and risk management approaches during commercial development and operations in order to be able to meet the requirements of the FDA’s current Good Manufacturing Practice (cGMP), which are contained in and are governed by regulations 21 CFR parts 210 and 211.

The FDA’s guidance on cGMP quality systems and risk management approaches is meant to help drug manufacturers implement…

Continue

The criticality of risk analysis to HIPAA implementation can be understood from the fact that inability to carry out this activity is the principal reason for which The United States Department of Health and Human Services (DHHS or just HHS) levies civil money penalties on Business Associates and Covered Entities.

This means that Covered Entities and…

Continue

Workplace Safety Regulations :

Workplace safety is a matter of grave importance to any organization. Ensuring the safety of workers is a primary goal of most countries, no matter which kind of political system or setup they have. This is because almost no workplace is free from some or another kind of hazard. These workplaces could be as varied as hospitals, construction sites, engineering plants or agriculture and many more.

Governments the world…

Continue

Understanding Medical Identity Theft and ways of preventing it

Medical Identity Theft is a common phenomenon in today's situation, where most health records are digitized. Although a lot of precaution goes into the security and protection of these records, Medical Identity Theft is a cause for worry.

The most common types of data that are stolen are Social Security Number (SSN), name and the Medicare number, the most potent tools with which to…

Continue

Did you see the stories in the newspapers that TV watching is bad for your health? It is but probably not for the reasons you might think. Certainly being a couch potato is unhealthy and if we sit there for long periods, eating chips, drinking beer and smoking cigarettes, our health will obviously take a turn for the worse. But a new study from Australian researchers observed 8800 adults for over six years and recorded the deaths from heart disease, cancer and all causes. The results were… Continue