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… Continue
Added by Compliance4all on July 19, 2018 at 8:23am —
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… Continue
Added by Compliance4all on July 17, 2018 at 5:28am —
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… Continue
Added by Compliance4all on July 12, 2018 at 7:45am —
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… Continue
Added by Compliance4all on July 9, 2018 at 6:49am —
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…
Added by Compliance4all on July 6, 2018 at 4:57am —
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…
Added by Compliance4all on July 3, 2018 at 5:32am —
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…
Added by Compliance4all on June 28, 2018 at 6:59am —
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…
Added by Compliance4all on June 14, 2018 at 7:18am —
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… Continue
Added by Compliance4all on June 5, 2018 at 5:47am —
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… Continue
Added by John Robinson on April 24, 2018 at 7:29am —
digital payment industry could be thrown into disarray due to the demand by the Reserve Bank of India (RBI) that all user data be stored within the country, fears an industry grouping, which has termed the decision as “heavy-handed”, even as others, including the country’s largest digital payment provider Paytm, have hailed the move.
In a bid to narrow the growing schism, the industry is planning to send a formal… Continue
Added by John Robinson on April 19, 2018 at 7:25am —
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… Continue
Added by John Robinson on April 17, 2018 at 7:47am —
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… Continue
Added by John Robinson on April 12, 2018 at 6:46am —
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… Continue
Added by John Robinson on April 10, 2018 at 7:07am —
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… Continue
Added by John Robinson on April 5, 2018 at 7:00am —
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®… Continue
Added by John Robinson on April 2, 2018 at 7:29am —
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.
Added by John Robinson on March 26, 2018 at 6:54am —
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…
Added by John Robinson on March 22, 2018 at 7:34am —
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.…
Added by John Robinson on March 20, 2018 at 7:13am —
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… Continue
Added by John Robinson on March 14, 2018 at 7:23am —