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Adam Fleaming's Blog (214)

RBI's latest norms makes Paytm happy, leaves Google, Amazon upset

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…

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Added by Adam Fleaming on April 19, 2018 at 7:25am — 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

FDA inspection is not going to invite an FDA action such as a 483 or a Warning Letter

If there is one common cause for apprehension between the smallest and biggest, and the best known and least known organizations; it has to be an FDA inspection! Any organization that is subject to an FDA inspection has to get absolutely everything of everything about its activities right to a T, to such an extent that it should be sure simply all the time, through all its processes, that an…

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Added by Adam Fleaming on March 1, 2018 at 6:16am — No Comments

When a medical device fails to meet these standards for precision and accuracy

All medical devices have their stated intended use. With time, many of them undergo changes with use. Because of this, they need to be calibrated to retain their effectiveness. The FDA’s medical device calibration requirements have been devised with the same intention.

Although the FDA has medical device calibration requirements, many of these medical devices do not have specific measures that need to be set. So, in view of this, the FDA can only require that the…

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Added by Adam Fleaming on February 27, 2018 at 4:57am — No Comments

FMEA in medical devices can work better when mated with ISO 14971

Failure Mode and Effects Analysis (FMEA) is a core aspect of risk management and risk analysis in medical devices. FMEA is essentially about analyzing the reasons for which a problem arises and the effects it has on the system. In the field of medical devices, it is absolutely critical to understand the failure mode and effects because the consequences of not doing this can be…

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Added by Adam Fleaming on February 23, 2018 at 5:38am — No Comments

Florida capital to press for gun law change

A hundred Stoneman Douglas High School students are busing 400 miles to Florida’s capital Tuesday to urge lawmakers to act to prevent a repeat of the massacre that killed 17 students and faculty last week.

The students plan to hold a rally Wednesday in hopes that it will put pressure on the state’s Republican-controlled Legislature to consider a sweeping package of gun-control laws, something some GOP lawmakers said Monday they would consider. Shortly after the shooting, several…

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Added by Adam Fleaming on February 20, 2018 at 5:02am — No Comments

FDA regulation on medical device packaging design

The FDA has regulations on medical device packaging design. This is quite natural, considering that the FDA has several regulations on all aspects of medical devices. However, it needs to be mentioned that the FDA regulation that covers medical device packaging design – Sec. 820.130 Device packaging under Subpart K–Labeling and Packaging Control -is a single liner, which only merely states that “each manufacturer shall ensure that…

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Added by Adam Fleaming on February 16, 2018 at 4:48am — No Comments

Medical Device Process Validation is the Key Part of a Quality Process

Process validation is one of the essential functions of a quality system for medical devices. Medical device manufacturers who have to stay compliant with regulatory requirements have to obtain premarket approvals (PMA), as well as premarket notifications for both new and modified existing medical devices. The key to all these is medical device process validation.

The FDA…

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Added by Adam Fleaming on February 14, 2018 at 5:03am — No Comments

FDA’s requirements on medical device product development process

One of the most elaborate prescriptions that the FDA has relates to the medical device product development process. This is because any error at any stage of the medical device product development process can result in serious repercussions for the patient. Since nothing is to be left to chance, the FDA has a series of steps in the medical device product development process. These are aimed at ensuring that there is total control of the device from the earliest to the…

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Added by Adam Fleaming on February 12, 2018 at 4:54am — No Comments

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Pro-Sapien announces new hosting service for Office 365 EHS software deployments

The new hosting service will open up the award-winning EHS system to mid-market organizations using Office 365 but who have not invested in Azure, the Microsoft Cloud.APRIL 19, 2018GLASGOW, UK • Pro-Sapien, provider of enterprise EHS&Q software on SharePoint and Office 365, has today announced an additional hosting option for clients. New customers can now opt to have Pro-Sapien manage the IT infrastructure, Microsoft Azure, required to access the EHS program.Up until now, clients using…See More
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Surviving A Commercial Construction Project

Whether you’re planning to expand your business’s current space or build a facility from the ground up, a commercial construction project is a good sign for your business. Commercial construction projects yield growth, which means your business is in a good position for the future. However, growth brings with it growing pains. Though it can be great in the long run for your business, a commercial construction project can bring some considerable headaches in the short term. Concerns about your…See More
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Python Condition Objects Tutorial in 2018

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

Tags: course, certification, training, languages, programming

Started by Elena Lauren Apr 2.

Automation Anywhere. How do I pick a value from dropdown 1 Reply

Automation Anywhere. How do I pick a value from dropdown. I tried 'set text' from a copied variable. Its very slow, and also doesnt…Continue

Tags: anywhere, automation

Started by emmablisa. Last reply by venkatesh Mar 29.

Agile overcome common software security challenges

Paradoxically, security is a negative goal. To secure something, you must understand how insecure it is. Start by trying to break it or by figuring out how other people might break it. The same is…Continue

Tags: agile, scrum, security

Started by nicolewells Mar 23.

Understanding Data Parallelism in MapReduce

In order to understand the goals of MapReduce, it is important to realize for which scenarios MapReduce is optimized. The MapReduce programming model is created for processing data which requires…Continue

Tags: program, Implementation, Mapreduce

Started by gracylayla Mar 14.

TensorFlow serving vs TensorFlow service

I have a question regarding the difference between TensorFlow Serving versus TensorFlow service. (Sorry that I'm not familiar with this at all.)I found TensorFlow serving's definition, which is "…Continue

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Started by emmablisa Feb 27.

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