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October 2017 Blog Posts (65)

IT’S A NO BRAINER! Action needed to stop children being exposed to chemicals that harm their brain development!

A report published today by CHEM Trust highlights how chemicals in food and consumer products used in homes, schools and offices could harm brain development in children.

The impacts – which may include ADHD and lower IQ – are avoidable and can prevent children reaching…

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Added by John Robinson on October 31, 2017 at 6:24am — No Comments

Putting an effective complaint and recall management system in place

Putting an effective complaint and recall management system in place1

Complaints very strongly show a company how its products or services are perceived where it matters the most -in the customer’s mind. Complaint handling is one of the key indicators of how seriously a business takes its customers’ point of view. Complaints are to be expected from about any product; but their importance is all the more felt in an area like medical devices, because these products can affect the very life of…

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Added by John Robinson on October 31, 2017 at 6:22am — No Comments

Introduction to Design Controls in medical devices

Design Control for medical devices can be understood as an integrated set of verifiable and demonstrable steps and practices undertaken by the manufacturers of these devices. Design Control for medical devices comprises a set of steps relating to the quality and consistency of medical devices, whose manufacturers take to ensure that:

  1. There is safety in the medical device under manufacture
  2. All the recommended and required steps and procedures that go into manufacturing…
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Added by Compliance4all on October 31, 2017 at 6:08am — No Comments

HIPAA and the role of the Security Officer

Security Officers or Compliance Officers have their task cut out when it comes to HIPAA implementation. With the changes taking place at the Health and Human Services (HHS) in relation to HIPAA enforcement; both Covered Entities and Business Associates need to insulate themselves from being vulnerable to audit risk. Any small letup will allow individuals whose PHI has been wrongfully disclosed due to bad IT or internal…

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Added by Roger Steven on October 30, 2017 at 7:50am — No Comments

Joe Stuntz on cybersecurity and One World Identity

Joe Stuntz was most recently the Policy Lead for the White House Office of Management and Budget (OMB) Cyber and National Security unit, now he works with One World Identity. We spoke with Stuntz about cybersecurity threats and solutions.

In October 2017, One World Identity, an…

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Added by Compliance4all on October 30, 2017 at 6:47am — No Comments

The use of Applied Statistics for FDA Process Validation

Why you Should be Worried about HIPAA The use of Applied Statistics for FDA Process Validation is considered a matter of very high importance in the pharmaceutical industry. The FDA’s guidance for the industry, which it called “Process Validation: General Principles and Practices”, was set up in 2011. This guideline sets the framework for Process Validation in the pharmaceutical industry. The FDA prescribes a three-stage process that any organization in the pharmaceutical industry has to set…

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Added by John Robinson on October 30, 2017 at 6:32am — No Comments

The science of Sad: understanding the causes of ‘winter depression’

The science of Sad

For many of us in the UK, the annual ritual of putting the clocks back for daylight saving time can be accompanied by a distinct feeling of winter blues as autumn well and truly beds in. This might be felt as a lack of energy, reduced enjoyment in activities and a need for more sleep than normal. But for…

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Added by John Robinson on October 30, 2017 at 6:28am — No Comments

Administering injectable and oral diabetic medications among cardiac patients

Hypertension is the silent killer of our times. Over thirty million Americans -one eleventh of the entire country’s population -suffer from this condition. It is rightly termed the silent killer because not only does it not show obvious symptoms; it works silently against the system when it is present. Neglected hypertension is a sure cause for strokes and heart attacks.

There is a highly undesirable, but strong and almost irrefutable link between cardiovascular disease (CVD) and…

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Added by Roger Steven on October 27, 2017 at 7:17am — No Comments

Second Death From Flesh-Eating-Bacteria Infection After Hurricane Harvey Is Reported

 

A 31-year-old man who helped to repair homes in Galveston, Texas after flooding caused by Hurricane Harvey was recently diagnosed with flesh-eating bacteria and died on October 16th after being admitted to a hospital on October 10th, according to a statement released by health officials in Galveston on Monday.

He is the second person to die from…

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Added by John Robinson on October 27, 2017 at 7:03am — No Comments

Heart surgery survival chances ‘better in the afternoon’

Heart surgery.jpg

Open heart surgery appears to be safer in the afternoon because of the body’s internal clock, scientists have said.

The body clock – or circadian rhythm – is the reason we want to sleep at night, but it also drives huge changes in the way our bodies work.

The research,…

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Added by John Robinson on October 27, 2017 at 7:00am — No Comments

Misinterpretation of closed Data when Treated with “Normal” Statistical Methods

Geology is among the many branches of science in which compositional data (CoDa) arise naturally. In branches such as geochemistry, compositional data seem to occur typically, when one normalizes raw data or when one obtains the output from a constrained estimation procedure, such as percentages, ppm, ppb, molar concentrations,…

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Added by Compliance4all on October 27, 2017 at 6:07am — No Comments

Forbes Talks Taxes, Healthcare in Address to Students

Forbes Talks Taxes, Healthcare in Address to Students

As Republicans struggle to score a legislative win on taxes, Steve Forbes dismissed fears that the American economy is doomed to slow economic growth or secular stagnation as “preposterous.”

Forbes, the chairman and editor-in-chief of Forbes Media and former Republican presidential candidate, blamed the current economic rut on correctable policy errors in a lecture sponsored by the Cornell Republicans on Wednesday.

The real source of…

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Added by John Robinson on October 26, 2017 at 6:36am — No Comments

Precision medicine: From ‘one-size-fits-all’ to personalized healthcare

Precision medicine From traditional to personalized healthcare Imagine a future in which, rather than using symptoms to identify a disease, your genes, metabolism, and gut microbiome inform how your individual health is managed. This is the vision of precision medicine.

Traditional medicine uses symptoms to diagnose diseases, and drugs to treat these symptoms. But precision medicine aims to turn this concept on its head.

By identifying the factors that predispose a person to a…

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Added by John Robinson on October 26, 2017 at 6:33am — No Comments

Shockingly few Americans are putting money in a 401k

There's a lot of hoopla surrounding President Trump's new tax plan, which is reportedly considering capping pre-tax 401(k) contributions at $2,400 a year , a far cry from the current maximum contribution of $18,000 for 2017, and…

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Added by Compliance4all on October 26, 2017 at 5:44am — No Comments

Easing the complexity of HIPAA enforcement

In the dozen years from the time of its enactment, change in thinking has been one of the palpable aspects of HIPAA. The advising and counseling outlook that characterized the initial years of its existence is now history. HIPAA is today noted for its very stringent and arm-twisting attitude. Its methods of enforcement are dreaded, to put it mildly. The coaxing and wheedling method used by the Office of Civil Rights (OCR) is now passé. The OCR is extremely unrelenting in its expectations…

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Added by Roger Steven on October 25, 2017 at 7:14am — No Comments

Sneak Peak into World’s Largest Flying Restaurant [Infographic]

World's largest flying restaurant - first class in Emirates First class cabin passenger in Emirates Airline enjoying her dinner. Photo-Emirates

How does a global airline like Emirates cater to the needs of its over 55 million customers? Here’s a neat infographic that gives you a glimpse into how Dubai’s flagship airline is…

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Added by John Robinson on October 25, 2017 at 6:33am — No Comments

Understanding Kidney Tumours

Kidneys are two bean-shaped organs located on the left and right side of the spine. They sit against the back muscles in the upper abdominal cavity. They are responsible for the extraction of waste from the blood, balancing body fluids, formation of urine, and facilitating other important functions of the body.

Kidney tumours are tumours (or growths) on or in a kidney and are also known as renal tumours. They can be benign (harmless) or malignant (leading to…

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Added by John Robinson on October 25, 2017 at 6:30am — No Comments

Centrelink delays leave recipients unable to pay for rent or food

Problems with Centrelink payments caused “extremely stressful” delays for some of Australia’s most disadvantaged groups this week, while newly released figures show complaints about the agency jumped by more than 50,000 in the last financial year alone.…

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Added by Compliance4all on October 25, 2017 at 5:44am — No Comments

Complaints Handling, Adverse Event Reporting, and Recalls call for an integrated approach

Complaints Handling, Adverse Event Reporting, and Recalls4

Medical device manufacturers work and operate in various regulatory systems whose requirements are different and not always consistent with each other. The new ISO version, the ISO 13485:2016, recognizes…

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Added by John Robinson on October 24, 2017 at 6:54am — No Comments

Learn How to manage and improve Human reliability

Manufacturing is a behemoth of an activity that straddles several industries. Modern manufacturing has come a long way from the days of its infancy, which can be traced to the Industrial Revolution of some 250 years ago. Getting advanced and refined at many stages; production or industrialization or manufacturing is the lifeblood of most of the world’s economies. Automation in the processes may have been introduced in many industries; yet, manufacturing…

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Added by Compliance4all on October 24, 2017 at 6:20am — No Comments

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