The demographic profile of the nation has a direct and very important bearing on the productivity of an organization. There is a common perception that the Baby Boomers are on their way out and are making way for Gen X. While this is true to on the surface, in the sense that Gen X is the next phase of the workforce; the Baby Boomers are certainly not done yet.
The key to getting more out of the American workforce is to analyze how one generation…
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Added by Adam Fleming on September 19, 2016 at 5:57am —
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The final regulations for the new HIPAA Breach Notification Rule place a far greater burden on Covered Entities and Business Associates than earlier. It is not enough for them to just notify individuals whose Protected Health Information (PHI) have been affected. For them to determine if a breach occurred, they must follow and document a very specific process. Their work does not end here. If no Breach occurred, then documentary evidence to this effect must be compiled and kept for…
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Added by Roger Steven on September 16, 2016 at 6:55am —
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Performing at least some verification testings or validation studies of design-outputs and/or manufacturing processes is essential for almost all manufacturing and development companies. Yet, it is sometimes difficult to explain the rationale that goes into the selection of the sample sizes used in such efforts.
Removing this doubt and showing participants a way out of this quandary will be the content of a webinar that Compliance4All, a leading…
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Added by Adam Fleming on September 16, 2016 at 6:29am —
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The NI (short for National Instrument) 43-101 is a Canadian national instrument used for the Standards of Disclosure for Mineral Projects within the country. This is a codified set of rules and regulations used to report and exhibit information relating to mineral properties owned by, or explored by companies that report these findings on the nation’s stock exchanges.
The NI 43-101 came into existence in the wake of the notorious Bre-X scandal. It…
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Added by Adam Fleming on September 15, 2016 at 6:37am —
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The Centers for Medicare and Medicaid Services (CMS) has proposed major changes into the Conditions of Participation for Discharge Planning. These changes will have a profound effect on case management departments, which are now required to put in place a plan of action that addresses the new requirements that will affect their departments. Among the changes that will be made are out-patient discharge planning assessments, 7 days a week/24 hours a day discharge planning, and care…
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Added by Roger Steven on September 13, 2016 at 8:41am —
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Documentation is at the heart of medical devices. If a medical device manufacturer cannot convincingly establish documentation of the manufacturing process; the medical device is bound to have regulatory approval hurdles. Every medical device manufacturer has to both establish and maintain all of these: documents, procedures and records, all of which must be under a state of control.
So, what should the documentation establish and prove?…
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Added by Adam Fleming on September 13, 2016 at 6:52am —
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Good Documentation Practice (GDP) constitutes the backbone of any GxP environment. Not only is GDP a sound business practice; it is also an FDA requirement. This being the case, it is absolutely essential for FDA-regulated organizations to get their GDP right. An organization that does not get its GDP right risks facing a number of consequences.
Today’s regulatory requirements are stricter than ever before. In this environment of very rigid regulatory environment;…
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Added by Adam Fleming on September 6, 2016 at 7:57am —
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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…
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Added by Roger Steven on September 2, 2016 at 6:56am —
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With the advent of globalization, the profile and nature of spread of many infectious diseases have changed. Earlier, many infectious diseases were limited to certain specific geographical regions. But this has changed with the emergence of the globetrotter. Additional factors such as globalization of trade and commerce and global warming have contributed significantly to propelling and motivating people to travel more and more all over the world. This trend has brought about a…
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Added by Roger Steven on September 2, 2016 at 6:37am —
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Although unfortunate; it is true that those who work in water systems design them keeping obsolete concepts in mind. Why this happens is that the water systems organization is reluctant to be open-minded enough to update its water systems from time to time. The result is that the water systems get built on a shaky foundation, making them fundamentally weak.
Myths are the backbone of water systems failures
An additional problem faced by most microbial monitoring…
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Added by Adam Fleming on September 2, 2016 at 6:12am —
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Clinical research regulations are directives that are aimed at making clinical research more effective and ethically justifiable. The tool or mechanism by which regulators ensure that clinical research regulations serve their purpose is what is called Good Clinical Practice (GCP).
Regulatory bodies around the world, irrespective of whether they function at national or global levels, formulate respective clinical research regulations that are aimed at ensuring that…
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Added by Adam Fleming on June 10, 2016 at 3:16am —
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Computer system validation process is described as the documented procedure which assures that a computer system performs the exact functions it is intended to reproducibly, consistently and verifiably. The computer system validation process covers every function and milestone of the computer system:
- Development of the system
- Operation of the system
- The system’s maintenance
- Its retirement
- Archiving…
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Added by Adam Fleming on June 7, 2016 at 2:24am —
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If one were to define validation; it can be considered the deed of testing an item or system for the level or extent to which it complies with a standard that it has to show compliance with.
In the case of computer systems, validation is a major requirement for these regulatory bodies/practices:
o The US FDA
o European Medicines Agency (EMA)
o Good Manufacturing Practices (GMP)
o Good Laboratory Practices (GLP)
o Good Clinical Practices (GCP)
o All the…
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Added by John Robinson on June 6, 2016 at 2:33am —
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The emerging discipline of Hospitals Management Performance Assessments
Over the past few years, Hospitals Management Performance Assessments have begun to gain acceptability and credence in healthcare circles. Hospitals Management Performance Assessments came into being as a result of a conscious effort by advanced countries, mainly European, with sufficient backing from the World Health Organization (WHO) to arrive at some sort of metrics…
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Added by Roger Steven on June 2, 2016 at 7:10am —
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If there is one common cause for apprehension between the smallest and biggest, and the best known and least known organizations; it has to be an FDA inspection! Any organization that is subject to an FDA inspection has to get absolutely everything of everything about its activities right to a T, to such an extent that it should be sure simply all the time, through all its processes, that an FDA inspection is not going to invite an FDA action such as a 483…
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Added by Adam Fleming on June 2, 2016 at 3:08am —
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It is important to ensure food safety in hospitals
Hospitals being what they are – where patients of almost all kinds visit or stay – are very potent sources of infection. Infection can arise from any part of the hospital. They can spread from patients to patients, from caregivers to patients, from patients to caregivers, from patients to support or administrative staff and vice versa, and so on. An often overlooked source of infection and contamination…
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Added by Roger Steven on June 1, 2016 at 7:16am —
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Airline and airport management courses are designed for those who want to make a career in the skies. Aviation has always been a preferred choice for a career. The existence of thousands of airports across the US -it has more than a third of the entire world's airports -and the large presence of aircraft for military and logistical purposes are major factors that prepare the ground for a career in airline and airport management. The prelude to a career in this field is to choose the right…
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Added by Adam Fleming on May 31, 2016 at 2:33am —
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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…
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Added by Roger Steven on May 30, 2016 at 3:50am —
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Project management is one of the core areas of expertise in today’s corporate career. Defined as a temporary allocation of resources to accomplish a defined goal and objective; project management may be considered the building blocks of an organization’s business. Given the importance of project management to any business; it is imperative that the organization implements a set of checks and balances into the whole system of project auditing to ensure that its project management is on track…
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Added by Adam Fleming on May 27, 2016 at 6:46am —
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Implementation of Regulatory Aspects of Clinical Research is critical
One of the prime areas of clinical studies is regulatory aspects of clinical research. This applies in almost equal measure to medical research as a whole. The FDA and other…
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Added by Roger Steven on May 27, 2016 at 5:07am —
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