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Adam Fleaming's Blog (221)

Education Technology’s Machine Learning Problem

From Formula 1 to Yelp, industries across the board are seeking ways to apply machine learning to their work. Even academics and Goldman Sachs analysts tried using it to predict World Cup winners. (Those predictions proved very, very wrong.)

But how is machine learning playing out in education—and how does it impact not just students, educators and parents, but also the businesses building technology tools to support teaching and learning?

At the SF Edtech Meetup, hosted by…

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Added by Adam Fleaming on July 12, 2018 at 7:45am — No Comments

Ask the SMXperts — Schema & Structured Data, JavaScript

Do you think Google will use Schema extensions built by experts?

Bill: There are subject matter experts and there are experts on creating Schema, and ideally an extension will involve both types of experts. To read up on extensions to Schema, there is a page on Schema.org…

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Added by Adam Fleaming on July 9, 2018 at 6:48am — No Comments

Blockchain Technologies to get Increasingly Powerful and Robust

You may be familiar with blockchain as the technology powering bitcoin cryptocurrency. But blockchain’s potential goes far beyond this, with healthcare being just one of the industries set to be revolutionized. In an editorial published today in the International Journal of Health GeographicsMaged N. Kamel Boulos and…

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Added by Adam Fleaming on July 6, 2018 at 4:57am — No Comments

Introduction of the new system is causing some concern over the privacy

A NEW controversial system may soon see welfare recipients required to have their face scanned and analysed before they can access their payments.

The system, which will also affect people trying access Medicare and childcare subsidies, age pension and pay tax online, is part of a new biometric security program that is set to begin in October.

Under the new strategy those trying to access these government services will be required to take…

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Added by Adam Fleaming on July 3, 2018 at 5:32am — No Comments

Improving Customer Experience with AI

A myriad of customer service channels exist today, such as social media, email, chat services, call centers, and voice mail. There are so many ways that a customer can interact with a business and it is important to take them all into account.

Customers or prospects who interact via chat may represent just one segment of the audience, while the people that engage via the call center represent another segment of the…

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Added by Adam Fleaming on June 28, 2018 at 6:59am — No Comments

What does the medical device/biotechnology auditor look for and why?

Audits -both internal and external -are a vital tool for ensuring that a medical device or biotechnology product and its manufacturing operations meet prescribed regulatory requirements. Medical device and biotechnology auditors have guidelines on how to establish that the manufacturer has met standards such as ISO 13485, ISO 14971, or regulations such as 21 CFR Part 820.

Apart from going by these guidelines; the auditor…

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Added by Adam Fleaming on June 14, 2018 at 7:19am — No Comments

Food Fraud in the Organic Industry

A recent admission by The U.S. Department of Agriculture’s Office of the Inspector General of its failure to review required documents for products labeled as “organic” indicates a lack of controls at U.S. borders, increasing the likelihood of nonorganic products entering the U.S. under false “organic” labels.

This opens the floodgates for the entry of dubious products into the market and getting passed off as organic, without being that. In fact, many imported products that carry the…

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Added by Adam Fleaming on June 5, 2018 at 5:47am — No Comments

Where does GMP Training end and HR training begin?

That pharmaceutical companies need to hire professionals with the requisite qualifications is beyond question. This is not only required for the smooth conduct of activities in their course of their day-to-day work, but also because the FDA has set out its requirements for the proper educational and skill set qualification of employees in this profession in 21 CFR 211.25(a).

This FDA section underlines the need for educational qualifications, training and experience to carry out their…

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Added by Adam Fleaming on April 24, 2018 at 7:29am — No Comments

Immunotherapy transforms lung cancer, the biggest cancer killer

Immune therapy drugs can transform lung cancer treatment, giving patients years of extra life, doctors reported Monday.

They found that pre-treating lung cancer patients with immune therapy drugs before they have surgery can help melt away the tumor and at the same time limit or even stop its spread.

And combinations of immunotherapy drugs have helped other lung cancer patients get off more toxic standard chemotherapy while also extending their lives.

The results are so…

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Added by Adam Fleaming on April 17, 2018 at 7:47am — No Comments

Which can leave the work of meeting regulatory requirements to FDA Services

FDA consulting services are those services that are offered by independent, mostly private companies in helping to meet FDA requirements. FDA consulting services are offered to organizations that have to meet FDA regulatory requirements. Many companies across the US and many other parts of the world specialize in offering FDA consulting services and these are often the main business for these…

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Added by Adam Fleaming on April 12, 2018 at 6:46am — No Comments

What happens when an FDA Form 483 is issued?

One of the chief aims of the FDA is to ensure the protection of public health and making sure that select types of organizations comply with the provisions of the Food, Drug and Cosmetic Act. It enforces these aims by conducting periodic inspections of the facilities and types of organizations that come under its purview. The FDA is empowered by the terms of the Federal Food, Drug, and Cosmetic Act, Sec. 704…

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Added by Adam Fleaming on April 10, 2018 at 7:07am — No Comments

Safe and effective as a non PMA-subjected legally marketed device

A medical device has to mandatorily make a submission for premarket approval (PMA) to the FDA to demonstrate that the device to be marketed is substantially equivalent or at least as safe and effective as a non PMA-subjected legally marketed device. This submission is called 510 (K).

A medical device company has to submit a product for PMA when it manufactures or makes changes and modifications that could substantially affect safety and effectiveness requirements under 21 CFR 807 and…

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Added by Adam Fleaming on April 5, 2018 at 6:59am — No Comments

PharmAbcine Announces FDA Orphan Drug Designation Granted to TTAC-0001

PharmAbcine Inc., a clinical-stage biotech company developing novel antibody therapeutics for multiple cancer indications, announced today that U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its leading clinical compound TTAC-0001 for “treatment of Glioblastoma Multiforme.”

“We are very pleased with this Orphan Drug Designation from FDA for TTAC-0001 for GBM treatment since we have been preparing for clinical studies of TTAC-0001 plus KEYTRUDA®…

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Added by Adam Fleaming on April 2, 2018 at 7:29am — No Comments

How to understand the Pharmaceutical Regulatory Affairs

Regulatory Affairs sit at the center of an industry like pharmaceuticals. Given the importance this industry and the products its manufactures have on the health of human beings; it is imperative that there should be regulations in the industry at every stage of the process of manufacturing and marketing of pharmaceuticals.

Pharmaceutical1-banner https://compliance4all14.files.wordpress.com/2018/03/pharmaceutical1-banner.jpg?w=706&h=664 706w,…

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Added by Adam Fleaming on March 26, 2018 at 6:53am — No Comments

How to understand the Pharmaceutical Regulatory Affairs

Regulatory Affairs sit at the center of an industry like pharmaceuticals. Given the importance this industry and the products its manufactures have on the health of human beings; it is imperative that there should be regulations in the industry at every stage of the process of manufacturing and marketing of pharmaceuticals.

Pharmaceutical1-banner https://compliance4all14.files.wordpress.com/2018/03/pharmaceutical1-banner.jpg?w=706&h=664 706w,…

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Added by Adam Fleaming on March 26, 2018 at 6:53am — No Comments

Virtual healthcare has to be understood and used for what it can offer

Among the many offshoots of the growth of technology; virtual healthcare is a very recent and important development. In simple language, virtual healthcare, a term easy enough to understand, is the use of technologies that enable remote consultation and monitoring of healthcare.

Putting technologies to remote use has been in use for a while now, what with corporate entities carrying out conferences and virtual conferences at the push of a button. Virtual…

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Added by Adam Fleaming on March 22, 2018 at 7:34am — No Comments

Good Documentation Practices Relating to USP

Good Documentation Practices (GDP) is a quintessential part of regulated manufacturing and laboratory environments. GDP has to be adhered to in the regulated industries because it is the only truly authentic method of ensuring that documents are audited and accounted for. GDP is also essential to keep track of and maintain control at all stages of the process and the product. GDP is thus a core requirement of a thoroughly developed Quality System.…

service-measuring-machine-gear

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Added by Adam Fleaming on March 20, 2018 at 7:09am — No Comments

Stephen Hawking’s secret to surviving his terrible condition

The late-night comic had found his perfect straight man. In June 2014, John Oliver sat down with renowned theoretical physicist Stephen W. Hawking for an interview.

“You’ve stated that there could be an infinite number of parallel universes,” the host of HBO’s “Last Week Tonight,” asked Hawking. “Does that mean there’s a universe out there where I am smarter than you?”

“Yes,” Hawking…

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Added by Adam Fleaming on March 14, 2018 at 7:23am — No Comments

Pharmaceutical Water Systems have to be Designed with a Lot of Common Sense

The effectiveness of a pharmaceutical water system depends on its design. The design is the soul of the system. Any pharmaceutical water system design should come equipped with the ability to serve its most basic purpose, which is to help the pharmaceutical organization meet the set quality.

The importance of water can never be overemphasized. Apart from the emotional, spiritual and cultural value it has; water also enjoys a position of complete primacy in the…

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Added by Adam Fleaming on March 12, 2018 at 5:48am — No Comments

Deaths in Dundalk

Suddenly. Beloved husband of Katherine and dear father of Mary, John and Kevin. Jerry had a long and personally rewarding career as a dedicated nurse, taking him into contact with many who truly appreciated his care. He will be sadly missed by his loving wife, sons, daughter, son-in-law Alan, daughter-in-law Grace, grandchildren Molly, Emma, Séan and Āine, brother Tommy, sister Betty, sisters-in-law, brothers-in-law, nephews, nieces, relatives, nursing colleagues, patients and many friends.…

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Added by Adam Fleaming on March 7, 2018 at 5:22am — No Comments

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Python Condition Objects Tutorial in 2018 1 Reply

If you have knowledge of other programming languages, then you would know the importance of conditional statements. Conditional statements are required for taking decisions. Whenever we operate the…Continue

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Power BI Visualization Types

Visualizations in Power BI displays the visual insights from a data. In power bi service a visual can be pinned from reports to create dashboards. Visuals are used in reports.List of visualizations…Continue

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