Regulatory compliance is something organizations in most industries have to deal with. Almost every industry has its own set of regulations that are framed by the respective regulatory bodies. In niche areas such as medical devices, pharmaceuticals, healthcare, finance, aerospace, information technology and such others, the FDA has a very detailed set of regulations.
The aim of these regulations…
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Added by Adam Fleming on August 28, 2018 at 7:22am —
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Metadata is the Achilles heel of video. These shorthand textual descriptions can be employed for more detailed searching, classification or other organizing, but, when scale is required, machine-generated metadata has accuracy issues.
On the other hand, the huge volume of video on the web makes human validation prohibitively expensive, so much video searching misses a lot of what’s visually…
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Added by Adam Fleming on August 24, 2018 at 8:05am —
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What makes FDA guidelines so addictive that you never want to miss them? Well, FDA guidelines are something like the reminders for your car servicing. What happens when you buy a car? You get reminders from your dealer asking you to service it on time. The reason: your car is meant to be in fine shape when you…
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Added by Adam Fleming on August 23, 2018 at 5:56am —
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When you work in an industry that is regulated by the FDA, one thing that is as certain as day and night is the fact of FDA regulation. Of course, this is as obvious as saying that solar power is derived from the sun and is as silly as asking if the FDA regulates FDA-regulated industries! The point being made is that regulation is the essence of the FDA’s existence. The FDA has been created to regulate certain industries with the intention of…
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Added by Adam Fleming on August 20, 2018 at 6:37am —
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Training is the foundation to producing products and services that meet regulatory and quality expectations and industrywide acceptance. This is generally true for all products and services, but in particular, for medical devices. Why? Medical devices are not in the same league as any other ordinary product that can be handled by anyone in any manner.
Training is the only means by which medical device companies that manufacture medical devices and the staff that handle these products…
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Added by Adam Fleming on August 13, 2018 at 6:41am —
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Well, a few things in life can be planned. A few things cannot. If only healthcare could be planned the way we plan our holidays! Despite all the advancements we have made in medical technology and the tall claims of our knowledge of the human mind and body, we are still a long way away from understanding…
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Added by Adam Fleming on August 8, 2018 at 5:00am —
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With almost everything under the sun being touched in one or another way by technology; medical devices are not exempt from this influence. Technology and medical devices have always had a strong bond with each other. Newer technologies that have sprung up over the past few years have accentuated their already strong linkage. So, which new technologies have the potential to impact medical devices in a big way? There are many, but let us consider…
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Added by Adam Fleming on August 6, 2018 at 4:46am —
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Healthcare compliance trainings are undertaken to get a clear idea about the regulatory compliance requirements in the industry. Healthcare is a highly regulated industry, which means that the regulatory bodies keep issuing regulatory guidelines, standards or requirements from time to time, as the regulations come in. One question that could arise in the minds of readers is: is it necessary to get trained…
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Added by Adam Fleming on August 1, 2018 at 6:05am —
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What is compliance? We all know the commonly used meaning of the term. One of the meanings The Oxford Online Dictionary has for compliance is its being “(t) he state or fact of according with or meeting rules or standards”. So, in the context of the regulated industries, compliance is being in a state of acquiescence or agreement with the regulatory requirements. The rules or requirements are set out by the regulatory authorities such as the US FDA or the European Union’s European Medicines…
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Added by Adam Fleming on July 30, 2018 at 7:02am —
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Information researchers have a developing scope of alternatives while picking systematic instruments, and another overview of hardware inclinations uncovers a generally even split in inclinations among the three driving programming dialects.
In its…
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Added by Adam Fleming on July 27, 2018 at 7:00am —
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Food inspections occupy a position of primacy among the FDA’s list of mechanisms aimed at maintaining and enhancing food safety. Since it is the sole regulatory body in the US for food, it is natural that the FDA attaches the highest importance to ensuring the safety and efficacy of food that is consumed across the nation.
Towards ensuring this, the FDA has initiated a number of plans and strategies. A seamless, informal and micro level activity in this list is risk-based food…
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Added by Adam Fleming on July 26, 2018 at 7:18am —
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It is hard to believe that it has been just over since five months since our second son, Lukas, was born on Feb. 3. His mother, Hollyanne, is doing well, which is something to be thankful for, given the excessive maternal mortality rates in the U.S. Lukas is also healthy and growing, albeit sleeping little at night. What is…
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Added by Adam Fleming on July 19, 2018 at 8:23am —
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Digital technology has been driving change throughout the life science industry for years, however the sector is currently standing on the precipice of revolutionary development – some organizations have already taken the jump towards a more digital future.
Data collection and visualization for decision making to improve the overall performance of themanufacturing supply chain is a huge opportunity for the life science industry, however it’s not about being new – it’s about using…
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Added by Adam Fleming on July 17, 2018 at 5:28am —
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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 Fleming on July 12, 2018 at 7:45am —
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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 Fleming on July 9, 2018 at 6:49am —
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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 Geographics, Maged N. Kamel Boulos and…
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Added by Adam Fleming on July 6, 2018 at 4:57am —
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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 Fleming on July 3, 2018 at 5:32am —
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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 Fleming on June 28, 2018 at 6:59am —
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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 Fleming on June 14, 2018 at 7:18am —
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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 Fleming on June 5, 2018 at 5:47am —
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