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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
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
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
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
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
PALMER TWP., Pa. – A Philadelphia woman is facing fraud charges after she allegedly arrived at a Northampton County pharmacy Wednesday night with fake prescriptions for more than 200 pills.
Police arrested Samantha M. Brown at a Palmer Township Rite Aid with fraudulent prescriptions for Oxycodone, Alprazolam and Flexiril. The 25-year-old now faces three felony counts of trying to acquire a controlled substance. District Judge James Narlesky…
Added by John Robinson on November 10, 2017 at 4:54am — No Comments
Supplies of thousands of medicines are at risk of disruption if Britain leaves the European Union without a trade deal, European pharmaceutical companies warned on Thursday. More than 2,600 drugs have some stage of manufacture in…
Added by John Robinson on November 9, 2017 at 5:48am — No Comments
The ISO 13485, which is the ISO’s global medical device standard; was upgraded significantly in 2016. This upgrade was carried out primarily to help the standard keep up with the changes that have taken place in the industry in about the decade and a half since the previous standard was brought into effect in 2003.…
Added by John Robinson on November 9, 2017 at 5:44am — No Comments
A phase 3 trial studying the effects of tolvaptan has found that the drug slowed the rate of decline in kidney function in patients with polycystic kidney disease…
A phase 3 trial studying the effects of tolvaptan has found that the drug slowed the rate of decline in kidney function in patients with the most common form of…
ContinueAdded by John Robinson on November 9, 2017 at 5:42am — No Comments
Murj, a new company backed by $4.5 million in new venture financing, is looking to make data collection from implantable heart monitoring and management devices easier and more manageable.
The company was founded by a former Medtronic sales rep who’d previously worked as a product manager on Apple’s iPads. After a few years in sales, Murj founder Todd…
Added by John Robinson on November 8, 2017 at 5:39am — No Comments
Process validation is the method of using data from stages ranging from the process design stage to production, to ensure that the process that is being used can deliver consistently high-quality products. Companies that come under the life sciences must comply with GxP regulations to ensure that their processes meet the regulatory guidelines to be GxP compliant.…
Added by John Robinson on November 8, 2017 at 5:37am — No Comments
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