The Food and Drug Administration (FDA) is the US’ regulatory agency for a variety of products that concern the health of their consumers. The FDA regulates everything concerning food, medicine, medical devices, veterinary products and cosmetics, as well as products that emit radiation. In addition to directly regulating all these through its set of regulations, the FDA also encourages innovation in the products and processes of products in these…
Added by Adam Fleming on November 2, 2018 at 6:30am —
A medical device inspection. Ah! Is there a more dreaded exercise for a medical device manufacturer? If I were given a choice between taking up the world’s toughest rated examination and facing a medical device inspection, I would gladly opt for the former. A medical device inspection should rank right there ahead of the most difficult examination or task.
Alright. We knew this fact all along. So, why should I intimidate you by casting such aspersions on a medical device inspection?… Continue
Added by Adam Fleming on October 30, 2018 at 6:29am —
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a US legislation that was enacted under the HITECH Act under Bill Clinton’s presidency with the intention of offering safeguards for medical information through its data privacy and security provisions. The Act consists of five sections. Also called titles, they are these:
- HIPAA Health Insurance Reform
- HIPAA Administrative Simplification
Added by Roger Steven on October 25, 2018 at 8:36am —
Trade and logistics, despite its relatively recent development, has gone on to become a global one. It is one of the many industries that have benefited in immeasurable ways by the growth of technology and globalization. It is no exaggeration to say that trade and logistics has exploded following these developments.
First, a basic understanding of the two:… Continue
Added by Adam Fleming on October 15, 2018 at 6:04am —
Information Technology (IT), which has traversed and influenced almost every area known to the human mind, has made a solid impact on healthcare. The healthcare industry in the US is the world’s largest, with some estimates putting its size at $ three trillion. Information Technology is an extremely useful and enabling tool in an industry of such proportions. Healthcare IT is now being considered a specialized branch of IT.
The role of IT in healthcare
IT works in innumerable ways in… Continue
Added by Roger Steven on October 11, 2018 at 9:16am —
Microsoft Excel is a wonder package, and in saying this, I am not exaggerating or taking sides with Mr. Gates’s developers. They have created a program that is so versatile and so tailor-made for just so many industries that you would wonder from where they got the idea to do this. I reckon they must have worked extensively with the industry closely in understanding its needs and implemented all the details with devilish diligence.… Continue
Added by Adam Fleming on October 10, 2018 at 3:13am —
Wondering if you should attend clinical compliance trainings? The following paragraphs will explain to you the criticality of clinical compliance trainings. We hope this article will help you understand why you should attend clinical compliance trainings.
First, let us… Continue
Added by Adam Fleming on October 8, 2018 at 5:43am —
Formally known as the “Public Company Accounting Reform and Investor Protection Act” in the US Senate and as the “Corporate and Auditing Accountability and Responsibility Act” in the House of Representatives, Sarbanes Oxley (SOX) is a landmark legislation that the American Congress passed in 2002. Named for the sponsors of this Bill, senators Paul Sarbanes and Mike Oxley, it was passed in the wake of the financial scandals of huge American… Continue
Added by Adam Fleming on October 5, 2018 at 3:18am —
The food and beverages industry, a global one, is an interesting bag of surprising and often contradicting facts. The food and beverages industry is a really global one, meaning there is almost no place on this planet that this industry does not cover. You are as likely to find a food joint in Mongolia as you are in Mozambique. The reason is simple: we can live without many things, but not without food. Any surprise that this industry is a giant,… Continue
Added by Adam Fleming on October 1, 2018 at 5:39am —
Trainings are a necessary ingredient for excellence in organizations. On-the-job training is almost a must for most employees at various levels in organizations. Trainings are necessary for a variety of reasons. Many employees who are just out of college may sometimes feel the need to get trained to help them understand the organization and the job better because the actual work the organization does may not be part of the curriculum they may…
Added by Adam Fleming on September 24, 2018 at 5:41am —
Like any other industry, the food and beverage industry too, is unique in its own way, carrying its own set of characteristics. It is a curious mix of the big and the small, not only in terms of the size of companies in it, but also the reach of these companies.
In a sense, the food and beverage industry is…
Added by Adam Fleming on September 19, 2018 at 6:27am —
What makes risk management critical? Well, business that comes with no risk is no business at all. It is like the side effect of a medicine. It is impossible to think of the medication without the side effects. Risk being inhered into a business and intricately woven into it; it is necessary to understand why you must keep carrying out risk management throughout your business’ lifetime. This places risk management right up there at the very top… Continue
Added by Adam Fleming on September 17, 2018 at 7:49am —
Requirements set out by the Occupational Safety and Health Administration (OSHA) are aimed at ensuring safety at the workplace. Formulated in 1971 under President Richard Nixon, it was one of the landmark legislations in any part of the world. Today, almost all kinds of workplaces in the US are regulated by OSHA.
Through its concerted efforts, OSHA has largely been a success, if one takes into… Continue
Added by Adam Fleming on September 14, 2018 at 6:25am —
How mental illness stigma affects social relationships
Mental illness is a peculiar issue from many perspectives. Firstly, mental illness does not show itself up very easily unlike a physical injury. Secondly, since it concerns the human mind, the most complex of all creations, its condition keeps varying according to the situation around the person having a mental illness. Thirdly, and most importantly, it is characterized by a very strong reaction from the society, or what we call… Continue
Added by Roger Steven on September 10, 2018 at 9:15am —
Good Clinical Practice (GCP) is a set of international standards meant for entities that conduct clinical trials. This set of standards, formulated by the International Conference on Harmonization (ICH), when implemented into clinical trials involving human subjects, seeks to ensure the protection of the humans involved in the research, as well as to bring about transparency in the methods of clinical practice.… Continue
Added by Adam Fleming on September 5, 2018 at 7:15am —
HIPAA compliance is, as any healthcare professional involved in work related to it in one or another way would attest, the most important requirement for a HIPAA-governed entity. Covered Entities and Business Associates have to comply with HIPAA regulations and safeguard HIPAA provisions with their lives, so to speak, because it is a matter of their very existence as a business entity.
A look at what happens in the event of HIPAA noncompliance is instructive:
Added by Roger Steven on September 4, 2018 at 8:51am —
Regulatory compliance is something organizations in most industries have to deal with. Almost every industry has its own set of regulations that are framed by the respective regulatory bodies. In niche areas such as medical devices, pharmaceuticals, healthcare, finance, aerospace, information technology and such others, the FDA has a very detailed set of regulations.
The aim of these regulations… Continue
Added by Adam Fleming on August 28, 2018 at 7:22am —
Metadata is the Achilles heel of video. These shorthand textual descriptions can be employed for more detailed searching, classification or other organizing, but, when scale is required, machine-generated metadata has accuracy issues.
On the other hand, the huge volume of video on the web makes human validation prohibitively expensive, so much video searching misses a lot of what’s visually… Continue
Added by Adam Fleming on August 24, 2018 at 8:05am —
What makes FDA guidelines so addictive that you never want to miss them? Well, FDA guidelines are something like the reminders for your car servicing. What happens when you buy a car? You get reminders from your dealer asking you to service it on time. The reason: your car is meant to be in fine shape when you…
Added by Adam Fleming on August 23, 2018 at 5:56am —
A HIPAA gap analysis is a crucial step for healthcare organizations in ensuring compliance with the HIPAA Security Rule. Why? An understanding of HIPAA gap analysis will help understand this question:
HIPAA gap analysis is defined by the US Department of Health and Human Services (HHS) as a means to evaluate or assess the extent to which there are lacunae in the implementation by the Covered Entities or their Business Associates, of the safeguards or privacy… Continue
Added by Roger Steven on August 22, 2018 at 8:05am —