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Adam Fleaming's Blog (197)

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

Medical Devices is aimed at ensuring very high quality assurance standards

Process validation for medical devices is a key ingredient of quality assurance in medical devices. Process validation is the criterion for measuring the effectiveness of a quality system for medical devices. The first step that medical device manufacturers have to take to show compliance with regulatory requirements for new and modified existing medical devices is obtaining premarket approvals (PMA) and premarket notifications. Process validation for medical devices is…

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Added by Adam Fleaming on February 6, 2018 at 5:09am — No Comments

CISOs map out their cybersecurity plan for 2018

When Omar F. Khawaja compiled his priority list for 2018, he didn’t include which security technologies he wanted or how many IT staff he hoped to hire.

Instead, the CISO at Highmark Health — a healthcare management and insurance provider whose portfolio includes Allegheny Health Network, United Concordia Dental and Visionworks, among others — articulated an overarching strategy on how the cybersecurity plan should fit within the national organization’s business…

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Added by Adam Fleaming on February 2, 2018 at 5:06am — No Comments

What is the purpose of lyophilization & Where it will be applied?

Lyophilization is the clinical term for freeze-drying. In the simplest terms, it can be described as a technical process in which the moisture level of many materials is reduced, most times frozen, for the purpose of creating a new product or an ingredient.

When an injectable drug is freeze-dried -this is the process of lyophilization -its compounds are stabilized. This reconstitution process is…

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Added by Adam Fleaming on January 25, 2018 at 5:12am — No Comments

Food Production Is A Modern Agricultural Miracle So Why Is It Under Attack

Agriculture is under attack. Environmentalists label modern farming as unsustainable, blaming farming for polluting the planet and destroying the climate. But today’s food is abundant and nutritious—a modern agricultural miracle.

From 1961 to 2013, world population more than doubled from 3.1 to 7.2 billion. But agricultural output more than tripled over the same period, according to data from the United…

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Added by Adam Fleaming on January 24, 2018 at 5:00am — No Comments

How a new technology is changing the lives of people who cannot speak

Last November, Joe Morris, a 31-year-old film-maker from London, noticed a sore spot on his tongue. He figured he’d bitten himself in his sleep and thought nothing more about it until halfway through the winter holidays, when he realised the sore was still with him. He Googled “cut on tongue won’t heal” and, after sifting through pages of medical information on oral cancer, he decided to call his doctor.

The cut was…

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Added by Adam Fleaming on January 23, 2018 at 5:06am — No Comments

To ICO or Not to ICO? That Is The Question for Today’s Startups

Aung Kyaw Moe and Jun Hasegawa have a lot in common.…

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Added by Adam Fleaming on January 22, 2018 at 5:30am — No Comments

Biocompatibility testing and evaluations for medical devices

Biocompatibility testing and evaluations for medical devices is a vital component of patient safety, for it is the only effective means to ensuring that a medical device or any related material, when it happens to come into contact with the patient’s body has to not only perform its intended purpose and function; it should also not result in adverse reactions for the patient.…

home-biology-toxicology

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Added by Adam Fleaming on January 19, 2018 at 4:59am — No Comments

Cyber security startups fall on harder times

SAN FRANCISCO (Reuters) – A wave of cyber attacks by criminals, spies and hacker activists should make these heady days for U.S. cyber security startups.

Instead, many in the crowded market are struggling to live up to their early promise. In some cases, the security products they developed have been overtaken by advances in cyber hacking, according to industry executives and venture capitalists. In others, larger competitors have come out with similar technology and locked down…

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Added by Adam Fleaming on January 18, 2018 at 5:15am — No Comments

Why It's So Hard To Shop For Health Care

Shopping for health care is kind of like going to a grocery store where there aren’t any price tags. That jar of spaghetti sauce might cost $4, or maybe $50. But in health care you typically don’t find out prices until you get to the checkout counter. People with one kind of card pay one price, those with another pay a different one, and you may do better or worse if you offer cash.

Last year Montana lawmakers, frustrated by how hard it is…

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Added by Adam Fleaming on January 17, 2018 at 5:04am — No Comments

EDITORIAL – Conor O’Dea: A coup for Cayman Finance

A standard disclaimer in investment literature warns that “past performance is not indicative of future results.” But in the case of Conor O’Dea, the financial services veteran recently selected as chairman of Cayman Finance, a waiver of that warning would be perfectly appropriate.

Mr. O’Dea’s sterling professional track record, decades in the making, gives us confidence in his ability to lead Cayman Finance, along with CEO Jude Scott, to new altitudes of success.

The new…

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Added by Adam Fleaming on January 16, 2018 at 5:22am — No Comments

Telehealth Gives Rural Missouri More Access to Health Care

ST. ROBERT, Mo. (AP) — With a population just shy of 5,000, the town of St. Robert lies just south of the heart of Missouri. It’s one of the many rural towns in the state that finds alternatives to health care access through the internet.

Since the early 1990s, the telehealth network has helped connect patients to health care providers from their own homes. Increasing…

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Added by Adam Fleaming on January 12, 2018 at 4:49am — No Comments

Brexit: May to meet UK financial services chiefs

The Prime Minister is set to meet with business leaders from the UK’s financial services industry as the government attempts to secure a Brexit deal that will include the sector.

Theresa May will talk with Barclays’ chief Jes Staley and Goldman Sachs International boss Richard Gnodde among others on Thursday.

financial-services https://compliance4all14.files.wordpress.com/2018/01/financial-services.jpg?w=150&h=55 150w,…

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Added by Adam Fleaming on January 11, 2018 at 4:45am — No Comments

An understanding of 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.

pharmaceuticalRegulatoryAffairs The primary aim of Pharmaceutical Regulatory Affairs is to ensure compliance with regulations that apply to every stage and process…

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Added by Adam Fleaming on January 10, 2018 at 4:49am — No Comments

IBM marks more than 100,000 patents in 25 years with AI, cyber security enhancements

The inventors who serve as the backbone of International Business Machines Corp. passed a significant milestone this year, and a diverse array of fields including artificial intelligence (AI), the cloud, and cyber security are all the richer for it.

The Armonk, N.Y.-based tech giant used this year’s Consumer Electronics Show…

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Added by Adam Fleaming on January 9, 2018 at 5:06am — No Comments

Army Chief stresses on indigenous defence technology

Asserting that there is huge requirement to modernise the armed forces, Army Chief General Bipin Rawat on Monday called for self-reliance in terms of defence equipment manufacturing. Speaking at the Army Technology Seminar in Delhi, General Rawat said: ” the time has come to ensure that we fight the next war with homemade solutions.”
robots-4 https://compliance4all14.files.wordpress.com/2018/01/robots-4.jpg?w=150&h=100 150w,…
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Added by Adam Fleaming on January 8, 2018 at 5:02am — No Comments

How the Future of Finance Gives You Total Control

In the world of commerce, internet is king as it never sleeps and continues to take transactions long after you and I have laid to rest for the night. With the evolution of finance and online transactions the internet world has taken large steps to make it easier for the consumer and investor to feel more safe and secure with the funds which are being processed.

Remember when Paypal came on the scene? “E-commerce”? It was still like a toddler –…

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Added by Adam Fleaming on December 1, 2017 at 5:10am — No Comments

The vital area of Pharmaceutical Process Engineering

Pharmaceutical Process Engineering is an often-overlooked area in the field of pharmaceutical manufacturing. It calls for a high degree of precision and coordinates technical expertise and communication between professionals involved at diverse levels of the manufacturing unit, such as pharmaceutical researchers, chemical engineers and industrial. It is concerned with how pharmaceutical development is related to the application of major concepts and…

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Added by Adam Fleaming on November 28, 2017 at 5:27am — No Comments

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Guidelines for Performing a Vendor Audit with an emphasis on Construction Audit at Training Doyens 26468 E Walker Dr,Aurora, Colorado

April 3, 2018 from 1pm to 2:30pm
OVERVIEWVendor/Contract audits require a certain skill set to understand the terms and conditions of a contract between a Company and any given vendor where products or services are outsourced.  Understanding the risks that are inherent within them is the first step in developing audit objectives and steps. The primary focus of the audit is the vendor (third party) activities pertinent to a contract. A majority of the fieldwork on these types of audits will likely be performed at the Vendor’s…See More
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How to begin your career in IBM API Connect? at 4608 Spalding, plano TX 75024 United States

February 19, 2018 to February 19, 2019
IBM API Connect is a complete API lifecycle management solution that will make things easier for developers, Central IT, and LoB Management. The thought behind API Connect is that APIs are small data applications, often called microservices, but they are applications nonetheless.IBM API Management with a built-in gateway, allowing you to create, run, manage, and secure APIs and Microservices. API Connect is the first of its kind: a unified end-to-end API management solution that enables the…See More
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Risk Management in the Global Economy and outlook for 2017

Risk management in the global economy is a highly challenging field for risk managers from any part of the world. With most of the world’s countries almost becoming part of the global economy in this era of globalization; it is emerging that risks that apply to one part any one nation’s or group of…See More
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Hot Issues in Multi-State & Internet Sales Tax at 26468 E Walker Dr, Aurora, Colorado 80016-6104

March 13, 2018 from 1pm to 2pm
OVERVIEWStates are tense. They need more revenue.Millions of dollars of internet sales occur daily without tax.  The states want their money. In just 90 minutes, learn the different ways your company triggers nexus on itself and what it must do to comply with state regulations.WHY SHOULD YOU ATTENDWill I owe taxes in more than one state for the same sale? Must I charge tax on my internet sales?  Why is my drop shipper charging me tax?  Why did I receive a NEXUS Questionnaire and what if I don’t…See More
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Occupational Health and Safety 7 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 Tony Ferraro yesterday.

About sailpoint software

An identity management system refers to an information system, or to a set of technologies that can be used for enterprise or cross-network identity management. Additional terms are used synonymously…Continue

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Started by sujathayarlagadda on Friday.

What can be essentials safety measures taken to secure campus?

Students safety inside and outside the school premises is a huge concern in today's risk environment. what measures should be taken to ensure campus security?Continue

Tags: security, campus

Started by Jen McDade Feb 6.

What can be essentials safety measures taken to secure campus?

Students safety inside and outside the school premises is a huge concern in today's risk environment. what measures should be taken to ensure campus security?Continue

Tags: security, campus

Started by Jen McDade Feb 6.

What are the advantages of IoT in healthcare Industry?

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Tags: Aware360, IoTin

Started by Jen McDade Feb 5.

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