If you want to get the best health care, you might be better off living in one of these states, according to a new ranking.
Hawaii, Iowa and Minnesota topped WalletHub’s new ranking of the best states for health care. The ranking took into…
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The FDA’s regulations on cleanroom environmental monitoring (EM) are based on the assumption that any person who enters a cleanroom is likely and almost certain to have brought contaminants in one or another form with him. The FDA’s regulations on cleanroom environmental monitoring are built on the thinking that microorganisms can assail even the cleanest of systems, which is why its regulations on cleanroom…
ContinueAdded by Adam Fleming on August 9, 2017 at 5:39am — No Comments
The medical profession is different from most others in one vital aspect: Practitioners of this profession don’t retire. The profession allows the physician to continue for as long as her physical and mental faculties allow her to. The US’ Supreme Court judges too, don’t retire, but theirs is judicial service, during which they are paid by the government, while a…
ContinueAdded by Roger Steven on August 8, 2017 at 7:00am — No Comments
If you want to get the best health care, you might be better off living in one of these states, according to a new ranking.
Hawaii, Iowa and Minnesota topped WalletHub’s new ranking of the best states for health care. The ranking took into…
Added by John Robinson on August 8, 2017 at 5:48am — No Comments
Quality controls in laboratories are a major area for which the FDA issues 483’s. A laboratory is the venue for many activities, all of them of varying importance to the product. When controls in laboratories are not up to the standard, such a laboratory could produce products that do not meet quality and processes expectations, and hence invite 483’s.
Issues with drug quality, drug integrity and data integrity, as well as data fabrication and human errors…
ContinueAdded by Adam Fleming on August 8, 2017 at 5:36am — No Comments
Software project management has an important tool in the Agile methodology. The Agile methodology developed as a product of the gradual efforts at arriving at a team…
Added by John Robinson on August 7, 2017 at 6:17am — No Comments
To say that the manufacturing industry is huge is to make a huge understatement. It is an activity that spans entire industries and is the lifeblood of many economies, right from advanced to developing ones. Despite the advancement in automation in the processes of many industries, manufacturing is still heavily dependent on human labor.
This makes manufacturing an activity that is prone to human error, because wherever there is human involvement, there is scope for human error. Why…
ContinueAdded by Adam Fleming on August 7, 2017 at 5:40am — No Comments
Healthcare providers have until September 23 to put into place internal policies and procedures needed to comply with sweeping changes coming to the Health Insurance Portability and Accountability Act (HIPAA).
In January, the U.S. Department of Health and Human Services (HHS) released a set of rules, known collectively as the omnibus rule, designed to supplement and modify the privacy, security, breach notification, and enforcement…
Added by John Robinson on August 4, 2017 at 5:53am — No Comments
The Hazard Analysis and Critical Control Point (HACCP) is a process control system that is aimed at identifying the points or areas at which hazards (dangers) may arise in the food chain. It prescribes strict measures for manufacturers and transporters of food products to prevent contamination and the resultant hazards. Control of hazards in the food chain has always been a need, but HACCP assumes added significance in today’s…
ContinueAdded by Adam Fleming on August 4, 2017 at 5:31am — No Comments
In any industry, compliance is everything; be it highly specialized fields such as the life sciences, healthcare, medical devices or non-technological areas such as food and clothing. Why do companies need to be compliant? It is simply because being in compliance with the required regulatory requirements helps the organization to achieve the most positive outcomes needed for a business:
Added by Adam Fleming on August 3, 2017 at 5:48am — No Comments
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
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