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There are various core components of a financial audit program. First, an understanding of a financial audit:
Added by John Robinson on November 30, 2017 at 5:37am — No Comments
Logistics and supply chain management (SCM) constitute a very important element of businesses. Getting the logistics and supply chain management aspects right is necessary for the smooth flow of products from their source to destination, during the course of which many activities need to be performed.
Logistics and supply chain management is emerging as a…
Added by John Robinson on November 29, 2017 at 4:53am — No Comments
The adverse event reporting system is an important highlight of the FDA’s adverse event reporting requirements. This is the mechanism through which adverse event reporting requirements are listed out for the FDA to take further action.
The adverse event reporting system may be understood as being a database…
Added by John Robinson on November 28, 2017 at 5:43am — No Comments
Pharmaceutical Process Engineering is an often-overlooked area in the field of pharmaceutical manufacturing. It calls for a high degree of precision and coordinates technical expertise and communication between professionals involved at diverse levels of the manufacturing unit, such as pharmaceutical researchers, chemical engineers and industrial. It is concerned with how pharmaceutical development is related to the application of major concepts and…
Added by Adam Fleming on November 28, 2017 at 5:30am — No Comments
The internal audit checklist for HIPAA is one of the primary elements of HIPAA implementation. The passage of the Health Insurance Portability and Accountability Act (HIPAA) by the U.S. Congress in 1996 was aimed at regulating the way and process by which healthcare institutions across the country reveal the medical information of their patients.
The Department of…
ContinueAdded by John Robinson on November 24, 2017 at 4:45am — No Comments
Medical devices and drugs clinical research have their differences in approach and methodology. It is necessary to have a clear understanding of these differences if one embarks upon a study involving either or both of these.
Some of the major differences between device and drug clinical research include:
Requirement for a study:
One of the important differences between device and…
ContinueAdded by Roger Steven on November 23, 2017 at 6:16am — No Comments
The new chief of the Philippines’ anti-drug agency has promised a fresh approach to the controversial war on drugs, “based on the rule of law”.
Aaron Aquino said that since he took over in August, only one suspect had been killed in 1,341 operations.
Thousands have died in the anti-drug campaign since it was launched by President Rodrigo Duterte in 2016.
Rights groups say Mr Duterte has sanctioned extrajudicial killings by vigilantes…
Added by Adam Fleming on November 23, 2017 at 4:55am — No Comments
The most critical aspect of risk management is the identification of potential areas of risk management. This helps the organization to stay focused on the areas in which it could possibly face risks, rather than taking an aimless view and shooting about in the dark.
In a very broad sense, the potential areas of risk management include all areas of a business, because simply…
ContinueAdded by John Robinson on November 23, 2017 at 4:41am — No Comments
With over four million employed directly or in allied sectors and catering to the world’s largest market and research area, biotech and pharma is a fast growing industry. Its courses are designed to prepare individuals for this giant industry.
Biotech and pharmaceutical courses are much sought after by aspiring…
Added by John Robinson on November 22, 2017 at 5:09am — No Comments
Auditing Quality Management Systems is a core requirement for ensuring that Quality Management Systems – defined as “…a set of policies, processes and procedures required for planning and execution” in the core business area of an organization, meaning those that impact the ability of the organization to meet…
Added by John Robinson on November 21, 2017 at 5:20am — No Comments
Good Manufacturing Practices (GMPs) constitute one of the core components that go into the manufacture and distribution of foods, drugs and other pharmaceutical products. Good Manufacturing Practices are prescribed by regulatory agencies from around the world, the FDA and the EMA being among them.
The guidelines set out by these regulatory…
Added by John Robinson on November 20, 2017 at 5:22am — No Comments
The US economy’s appetite for ingesting food imports is phenomenal, to use a mild term. How else does one describe an economy that takes in $49 billion a year? Considering that the FDA is the sole regulating agency that is tasked with overseeing imports of this magnitude, who can envy its responsibility? This is not all that the FDA does: its allied regulatory agencies monitor about half a million facilities in the US and abroad.
Since foods from…
Added by Adam Fleming on November 17, 2017 at 5:23am — No Comments
Registering and maintaining combination products in the US and the EU is a bit tricky, because these are disparate markets that are governed by different sets of regulations which are independent of each other. So, any business that wants to market combination products into the US or the EU must be completely aware of the nature and…
Added by John Robinson on November 17, 2017 at 5:22am — No Comments
Forward, the San Francisco-based startup that’s looking to refashion healthcare services in Apple’s image, is…
Added by John Robinson on November 16, 2017 at 5:07am — No Comments
Misuse of social media is a critical area of HIPAA privacy. A random act of carelessness by a healthcare worker can result in a Protected Health Information (PHI) breach, inviting actions from the HHS. As is known, protection of patient health information is what HIPAA is essentially all about. Many safeguards and safety mechanisms have been put into HIPAA to ensure this.
However, the rise of the social media has brought in a new dimension to PHI. Patient confidentiality can be…
ContinueAdded by Roger Steven on November 15, 2017 at 5:45am — No Comments
Arizona has a serious doctor shortage. The state is a “Designated Health Professional Shortage Area” and according to the latest numbers from the Health Resources &…
Added by John Robinson on November 15, 2017 at 5:20am — No Comments
Providing health care services in rural areas is vital to addressing health disparity needs in the United States, said Candice King, the ACORN clinic’s executive director.
To get dental services she can afford, 73-year-old Juanita Jenkins has one of her sons drive her 16 miles from her home in the Duval neighborhood in northeast Gainesville to the Alachua County Organization for Rural Needs…
Added by John Robinson on November 15, 2017 at 5:17am — No Comments
Health Education England is launching an online workshop to gather views on digital readiness.
The organisation is working in collaboration with Digital Health and innovation and crowdsourcing agency Clever Together on the online workshop, which forms part of the…
Added by John Robinson on November 14, 2017 at 5:32am — No Comments
Statistics is extremely useful as a decision-making tool in the clinical research arena. In areas such as working in a field where a p-value can determine the next steps on development of a drug or procedure, it is very handy, because of which it is imperative for decision makers to understand the theory and application of…
Added by John Robinson on November 13, 2017 at 5:44am — No Comments
The US economy’s appetite for ingesting food imports is phenomenal, to use a mild term. How else does one describe an economy that takes in $49 billion a year? Considering that the FDA is the sole regulating agency that is tasked with overseeing imports of this magnitude, who can envy its responsibility? This is not all that the FDA does: its allied regulatory agencies monitor about half a million facilities in the US and abroad.
Since foods from almost every country in the world are…
ContinueAdded by Adam Fleming on November 13, 2017 at 5:22am — No Comments
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