Adam Fleming's Blog (255)

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.…

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…

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…

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,…

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…

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…

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.…

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…

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…

When you work in an industry that is regulated by the FDA, one thing that is as certain as day and night is the fact of FDA regulation. Of course, this is as obvious as saying that solar power is derived from the sun and is as silly as asking if the FDA regulates FDA-regulated industries! The point being made is that regulation is the essence of the FDA’s existence. The FDA has been created to regulate certain industries with the intention of…

Training is the foundation to producing products and services that meet regulatory and quality expectations and industrywide acceptance. This is generally true for all products and services, but in particular, for medical devices. Why? Medical devices are not in the same league as any other ordinary product that can be handled by anyone in any manner.

Training is the only means by which medical device companies that manufacture medical devices and the staff that handle these products…

Well, a few things in life can be planned. A few things cannot. If only healthcare could be planned the way we plan our holidays! Despite all the advancements we have made in medical technology and the tall claims of our knowledge of the human mind and body, we are still a long way away from understanding…

With almost everything under the sun being touched in one or another way by technology; medical devices are not exempt from this influence. Technology and medical devices have always had a strong bond with each other. Newer technologies that have sprung up over the past few years have accentuated their already strong linkage. So, which new technologies have the potential to impact medical devices in a big way? There are many, but let us consider…

Healthcare compliance trainings are undertaken to get a clear idea about the regulatory compliance requirements in the industry. Healthcare is a highly regulated industry, which means that the regulatory bodies keep issuing regulatory guidelines, standards or requirements from time to time, as the regulations come in. One question that could arise in the minds of readers is: is it necessary to get trained…

What is compliance? We all know the commonly used meaning of the term. One of the meanings The Oxford Online Dictionary has for compliance is its being “(t) he state or fact of according with or meeting rules or standards”. So, in the context of the regulated industries, compliance is being in a state of acquiescence or agreement with the regulatory requirements. The rules or requirements are set out by the regulatory authorities such as the US FDA or the European Union’s European Medicines…

Information researchers have a developing scope of alternatives while picking systematic instruments, and another overview of hardware inclinations uncovers a generally even split in inclinations among the three driving programming dialects.

In its…

Food inspections occupy a position of primacy among the FDA’s list of mechanisms aimed at maintaining and enhancing food safety. Since it is the sole regulatory body in the US for food, it is natural that the FDA attaches the highest importance to ensuring the safety and efficacy of food that is consumed across the nation.

Towards ensuring this, the FDA has initiated a number of plans and strategies. A seamless, informal and micro level activity in this list is risk-based food…