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 Compliance4all 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 Compliance4all 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 Compliance4all 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 Compliance4all 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 Compliance4all 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 Compliance4all 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 Compliance4all 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 Compliance4all 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 —
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… Continue
Added by Compliance4all on August 20, 2018 at 6:37am —
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… Continue
Added by Compliance4all on August 13, 2018 at 6:41am —
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… Continue
Added by Compliance4all on August 8, 2018 at 5:00am —
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… Continue
Added by Compliance4all on August 6, 2018 at 4:46am —
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… Continue
Added by Compliance4all on August 1, 2018 at 6:05am —
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… Continue
Added by Compliance4all on July 30, 2018 at 7:02am —
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… Continue
Added by Compliance4all on July 27, 2018 at 7:00am —
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… Continue
Added by Compliance4all on July 26, 2018 at 7:18am —
It is hard to believe that it has been just over since five months since our second son, Lukas, was born on Feb. 3. His mother, Hollyanne, is doing well, which is something to be thankful for, given the excessive maternal mortality rates in the U.S. Lukas is also healthy and growing, albeit sleeping little at night. What is… Continue
Added by Compliance4all on July 19, 2018 at 8:23am —