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The ISO 13485: 2016

The ISO 134855

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.…

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Added by John Robinson on November 9, 2017 at 5:44am — No Comments

Lonza news Tolvaptan identified as a treatment for autosomal dominant 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 polycystic kidney disease…

Tolvaptan identified

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…

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Added by John Robinson on November 9, 2017 at 5:42am — No Comments

Using MS Excel for Component Interface utility

A Component Interface (CI) helps expose a PeopleSoft component -defined as a set of pages grouped together for a business purpose -for synchronous access from another application such as PeopleCode, Java, C/C++, COM, or XML. One can think of CI’s as black boxes that capture and compress PeopleSoft data and business processes, while hiding the details of the underlying page and data.

CI's can be used for integrating one application with either another application or with external…

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Added by Adam Fleaming on November 9, 2017 at 4:30am — No Comments

Murj wants to give data collection from implantable medical devices an upgrade

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…

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Added by John Robinson on November 8, 2017 at 5:39am — No Comments

Testing GxP system that is FDA-compliant

Testing GxP system that is FDA-compliant

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.…

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Added by John Robinson on November 8, 2017 at 5:37am — No Comments

Study finds link between increased brain glucose levels and Alzheimer’s

A new study published yesterday in Alzheimer’s & Dementia: the Journal of the Alzheimer’s Association, found a link for the first time between abnormalities in the mechanism of glucose breakdown in the brain and the severity of tangles and amyloid plaques in the brain, as well as the commencement of visible symptoms of Alzheimer’s disease.…

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Added by John Robinson on November 8, 2017 at 5:33am — No Comments

5 Ways to Maintain a Clean Eating Lifestyle During the Busy Holiday Season

Sometimes, we all just need a little inspiration to stay on-track to eat healthy meals, especially when life gets busy. With the holidays around the corner, consumers are surrounded by more opportunities to eat decadent dinners and indulgent party appetizers. That's why the Just BARE® chicken brand, known for raising goodness by providing good food for more people, launched its Living Lean & Clean campaign. 

Experience the interactive…

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Added by Adam Fleaming on November 8, 2017 at 5:06am — No Comments

Understanding the infinite area of medical device compliance

Understanding the infinite area of medical device compliance 1.png With a seemingly unlimited number of products coming under the broad umbrella of medical devices; it is but natural that regulations for these products are equally expansive. This makes medical devices compliance an extremely enormous and broad topic.

With the FDA…

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Added by John Robinson on November 7, 2017 at 5:06am — No Comments

Microbiome, Diet, Health, and Disease: Policy Needs to Move Forward

Microbiome, Diet, Health, and Disease.jpg

This article covers policy needs concerning the rapidly evolving field of microbiome and diets with respect to health and disease. It captures some key outcomes of a multi-stakeholder dialogue (Brussels, May 2016), spearheaded by a joint effort of the Organisation for Economic Co-operation and Development (OECD) and the Department of Economy, Science and Innovation of the Flemish Government (Belgium), to help design and/or interpret regulatory…

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Added by John Robinson on November 7, 2017 at 5:04am — No Comments

GSK therapy for multiple myeloma receives breakthrough therapy designation

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Added by John Robinson on November 7, 2017 at 5:00am — No Comments

Stress And Your Overall Health

It is important to make sure that you and your employees understand the effects stress can have on your overall health.

This infographic was created by McLean DDS

Added by Dr. Jeena Devasia on November 6, 2017 at 9:40am — No Comments

Human Factors In Safety: How do stress and fatigue affect work?

What do we mean by human factors, and why are they important?

"Human factors refer to environmental, organisational and job factors, and human and individual characteristics, which influence behaviour at work in a way which can affect health and safety" Health and Safety Executive

Every person is different, meaning that there are as many variables to a job as there are people.…

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Added by Tytti on November 6, 2017 at 9:35am — No Comments

Australia’s health watchdog accused of ‘too close’ relationship with industry

Australia’s drug and medical device watchdog, the Therapeutic Goods Administration, needs a complete overhaul to distance it from the health industry and allow consumers to sue it for negligence, say academics and consumer advocates after the regulator quietly announced moves to classify all pelvic mesh devices high risk after years of controversy.

“The current regulatory framework is a complete bypass of the interests of consumers. They don’t have a stake…

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Added by John Robinson on November 6, 2017 at 5:20am — No Comments

Project Management is important for non-Project Managers, too

Project Management is important for non-Project Managers, too

A few skills need to be imbibed by professionals, even if they are out of their domains or area of expertise. This is because when it comes to handling crunch situations; one cannot expect a manager to…

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Added by John Robinson on November 6, 2017 at 5:17am — No Comments

Orkambi Reduces Main Biomarker of CF, Vertex Says in Updated Results on Four Therapies

Orkambi Reduces

Orkambi (lumacaftor/ivacaftor) reduced levels of the main biomarker of the lung disease cystic fibrosis and improved the nutritional status of children with the condition, according to a Phase 3 clinical trial.

The results were part of a recent update that Vertex…

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Added by John Robinson on November 3, 2017 at 6:25am — No Comments

Statins ‘should be given to children with heart risks before the age of 10’

Statins 'should be given

Statins should be given to thousands of children by the age of 10 under radical new NHS guidance.

GPs are being urged to identify those who have an inherited risk of high cholesterol, amid warnings that the vast majority of cases are going undetected.

Estimates suggest up to 260,000 people –…

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Added by John Robinson on November 3, 2017 at 6:24am — No Comments

GMP and Regulatory Expectations for Early IND Products

 GMP and Regulatory Expectations for Early IND Products What the FDA’s recent guidance documents covering GMP requirements for Phase I products have done is to significantly reduce a few of the complexities that early phase products are typically against. These guidance documents are in addition to those that cover the CMC sections for IND submissions at Phase I.

These new…

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Added by John Robinson on November 3, 2017 at 6:21am — No Comments

Companies continue to increase transparency of external audit oversight

More companies are providing investors and other stakeholders with information about audit committee oversight of external auditors, according to the latest edition of the Audit Committee Transparency Barometer, an annual report released Wednesday by the Center for Audit Quality (CAQ) and Audit Analytics.

“For the fourth year in a row, audit committees have continued to…

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Added by Adam Fleaming on November 3, 2017 at 5:48am — No Comments

Process Development and Validation rest on the right Design of Experiments and Statistical Process Control

Design of Experiments and Statistical Process Control1.jpg

The application of DOE and SPC to the development, design and monitoring of manufacturing and testing requires the use of procedures. Why? It is because in a recent guidance document on Process Validation, the FDA has named the Quality Unit as being responsible in the review and interpretation of DOE and SPC studies.

The Quality…

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Added by John Robinson on November 2, 2017 at 6:49am — No Comments

Video of father comforting newborn son receiving his first vaccines goes viral

Video of father comforting.jpg

On October 26, first-time father Antwon Lee took his two-month-old son Debias King to get his first vaccinations. Lee, 29, said he was very nervous for the appointment, telling People Magazine that he “felt kind of scared a little bit,” as he knew the child was…

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Added by John Robinson on November 2, 2017 at 6:45am — No Comments

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Silvia Watson posted a blog post

How Can Crossfit Training Keep You Healthy and Fit?

CrossFit is the best way to keep your body active, your mind intrigued and your system alive. This is a high-intensity workout routine that involves strength building, muscle building and weight training activities along with intense aerobic workouts. People who indulge in CrossFitting at least once in a week are faster, nimbler and retain top shape throughout the workout time span.…See More
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John Robinson posted a blog post

Regulations in the US and EU Dealing with Combination Products

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 meaning of all the regulations. Such businesses…See More
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Adam Fleaming posted blog posts
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Alex posted a blog post

3 essential electrical safety tips for new students

Living away from home for the first time is an exciting, invigorating, and pretty daunting experience. While your first days at uni will be the time of your life, living away from your parents also comes with a new set of challenges.Aside from cooking and cleaning, one thing we take for granted is our parents’ knowledge of how to keep us safe. Electrical safety, in particular, is something not many first-time students know a lot about, but electrical accidents are…See More
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Occupational Health and Safety 5 Replies

Health and safety are important aspects of an organisation’s smooth and effective functioning.  Did you know that workplace health & safety injuries cost Australian businesses over $60 billion…Continue

Tags: Safety, and, Health, Occupational

Started by WHS Solutions. Last reply by Tara safe on Thursday.

QlikView for its Safety Strategic Business Intelligence Solution Worldwide

QlikTech (NASDAQ:QLIK), a leading…Continue

Tags: Qlikview, safety

Started by nicolewells on Wednesday.

What's your favorite motivational/safety quote? 102 Replies

Favorite Motivational Quote: If you want something, you'll find a way - If not, you'll find an excuse.Favorite Safety Quote: Don't learn safety by accident!Continue

Started by Michelle Sears. Last reply by David Collins on Tuesday.

Business Intelligence with Big Data happens at Unipê

the college center of João Pessoa will preserve the 1st assembly at big records, geared toward professionals inside the regions of administration, economics, public control and facts technologies.…Continue

Tags: qliksensetraining, qliksenseonline, qliksense

Started by Soujanya Naganuri Nov 1.

Road Safety Solutions 13 Replies

The Road Safety Signs ,Barriers,Humps,Hazard Markers and Visual Warnings are some of the important marks to be observed. Signs such as "keep left",stop, "give way" should not be casually treated.…Continue

Tags: safety, gear, wear, Equipment, &

Started by Enna Henry. Last reply by Barry Oct 26.

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