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Most healthcare providers or organizations that are described as Covered Entities by HIPAA, engage vendors as HIPAA Business Associates for carrying out many of their services on their behalf. HIPAA defines a Business Associate as a person or an entity who carries out some or all functions or activities that involve the use or disclosure of Protected Health Information on behalf of, or of providing services to a…
ContinueAdded by Roger Steven on August 2, 2017 at 8:13am — No Comments
Software as a Service, SaaS is a method of delivering applications over the Internet. This small definition just about summarizes the core of SaaS: It provides Software as a Service using just the Internet. SaaS applications go by different nomenclatures such as on-demand software, hosted software, or web-based software.
SaaS is a fundamentally different method of delivering applications, because when a client chooses SaaS;…
Added by John Robinson on August 2, 2017 at 6:50am — No Comments
Mastering MS Excel formulas and functions can make a miracle out of this program. When used optimally, MS Excel can be a wonderful tool for carrying out umpteen functions and optimizing work related to a number of departments. For example, the Accounts Department can do a number of important functions such as loan repayment calculation, generating a profit and loss statement, solve complex mathematical and engineering problems, and carry out anything that involves addition, subtraction,…
ContinueAdded by Adam Fleming on August 2, 2017 at 5:35am — No Comments
It is said that a picture is worth a thousand words. This adage may appear figurative and allegorical when applied to the realm of statistics, but there is no denying the fact that a visual approach to statistics enlivens the subject like no other. A dash of pictorial work and some coloring at the right places enhance the…
ContinueAdded by John Robinson on August 1, 2017 at 6:03am — No Comments
Hazard Analysis and Critical Control Point (HACCP) is an important system aimed at bringing down the risk of safety hazards found in food consumed all over the world. It is an internationally recognized system. When it was enacted in January 2011 as part of the FDA’s Food Safety Modernization Act; it was considered a very sweeping piece of legislation for the food industry.
Identification and control of…
ContinueAdded by Adam Fleming on August 1, 2017 at 5:39am — No Comments
A number of reasons make cultivation of the art of effective legal writing skills for FDA submissions important. Documents that are submitted to the FDA are…
Added by John Robinson on July 31, 2017 at 6:28am — No Comments
In September 2014, the FDA deployed a new risk-based screening tool for imports called the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT). The main aim of PREDICT was bringing about improvement in screening and targeting of adulterated or misbranded goods or those that flout any of the FDA’s rules. The FDA seeks to bring this about by doing away with its legacy electronic system, OASIS’ admissibility screening function.
PREDICT is an important tool…
ContinueAdded by Adam Fleming on July 31, 2017 at 5:28am — No Comments
Since the Affordable Care Act (ACA) –popularly called Obamacare –came into existence, there has been an exponential increase in the number of physician practice acquisitions. Some of the reasons that can be ascribed for this phenomenon are these:
- Physician practice acquisitions are an opportunity for healthcare providers in consolidating and…
ContinueAdded by Roger Steven on July 28, 2017 at 7:30am — No Comments
Added by John Robinson on July 27, 2017 at 6:09am — No Comments
Added by John Robinson on July 27, 2017 at 6:08am — No Comments
An effective audit constitutes the heart of an effective Quality System. The FDA and other regulatory agencies have emphasized this principle time and again. The purpose of an audit program is to ensure proper and thorough compliance with the guidelines set out by the regulatory agencies. A…
Added by John Robinson on July 26, 2017 at 5:52am — No Comments
Carrying out audits is among the most important requirements for any organization that handles Protected Health Information (PHI). HIPAA hosting providers, who implement safeguards in the manner specified in the HIPAA Privacy Rule, must be included in these audits. The indispensability of audits…
ContinueAdded by Roger Steven on July 25, 2017 at 8:00am — No Comments
If you had to name the branch of university research that has the most tangible impact on mankind’s day-to-day activities, it is likely that the life sciences would be near the top of the list: not many days go by without the announcement of a new drug or gene discovery that has the potential to change lives or tackle disease.
Much of the best research in these fields takes place in the ultra-elite universities that excel in subjects across the…
Added by John Robinson on July 25, 2017 at 6:14am — No Comments
Professionals in the field of statistical analysis need to possess clarity on understanding and interpreting statistical concepts used to investigate quantitative ICH Guidelines, such as:
Added by John Robinson on July 24, 2017 at 6:07am — No Comments
Aseptic technique is one of the methods used in eliminating or at least minimizing contamination in pathogens. It is also used to make compounding sterile products. Sterilized equipment, sterile apparel, high degree of processing, and cleaning on a continuous basis make up the important procedures used in aseptic technique.
The main aim of aseptic technique in cleanrooms is to ensure that the sterile product is sterile, safe and effective. Ensuring this is all the more important for…
ContinueAdded by Adam Fleming on July 21, 2017 at 6:08am — No Comments
The fact that medical device manufacturers work and operate in various regulatory systems whose requirements are different and not always consistent with each other is recognized and empathized by the…
Added by John Robinson on July 21, 2017 at 5:56am — No Comments
The North American Free Trade Agreement (NAFTA) came into being on the first day of 1994. While the US and Canada had been having free trade agreements that go back at least three decades culminating in the US-Canada Free Trade Agreement of January 1, 1989; NAFTA became a reality following Canada’s entry in 1991 into the bilateral talks between the US and Mexico, creating the trilateral FTA.
One of the primary objectives of the NAFTA was the elimination of a number of duties and…
ContinueAdded by Adam Fleming on July 20, 2017 at 5:26am — No Comments
Training and Development is a highly developed and evolved, broad body of knowledge. Many employees place themselves at a disadvantage vis-à-vis their colleagues in the absence of the right professional training and development. If employees have to consistently close gaps in their learning, they need to keep…
Added by John Robinson on July 19, 2017 at 6:21am — No Comments
Product Risk Management is a critical aspect of ensuring medical devices are safe and effective for intended uses. This course will help you understand the regulatory requirements, including ISO14971.
You’ll learn techniques that can help you identify hazards and potential harms. You’ll learn how to mitigate risk and effectively monitor risk to ensure your customers receive safe and effective products. A rigorous…
ContinueAdded by Adam Fleming on July 19, 2017 at 5:47am — No Comments
Stark Law compliance is now more than just a compliance issue. It has grown to become an Enterprise Risk Management matter, if the substantial awards and settlements in recent enforcement actions are anything to go by. For healthcare organizations that develop and implement provider contracts; managing their compliance and enterprise risk by ensuring that…
ContinueAdded by Roger Steven on July 18, 2017 at 7:50am — No Comments
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