Of late, the FDA and the Customs and Border Patrol Service (CBP) have become increasingly agile, smart, sophisticated and demanding when it comes to the submission of information and adherence to government procedures from importing firms. The FDA and the CBP can delay, detain or refuse shipments of firms do not properly execute an…
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Added by John Robinson on October 23, 2017 at 6:24am —
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In this era of globalization; outsourcing has become a major component of business. Outsourcing brings many benefits for companies. Short and long-term cost benefits, the ability to concentrate on their core activities and grow their business, and the freedom of avoiding the actual tasks that go into manufacturing are some of the stated…
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Added by Adam Fleming on October 19, 2017 at 6:20am —
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Dissolution testing is a very important tool that determines and help understand the performance and effectiveness of oral solid dosage forms. It is significant for the field of medicine because if a drug has to be effective, it must be released first from the product form, and it should then be allowed to get dissolved in the gastrointestinal fluids. This is the first step that leads to the next important phase, that of the dosage’s absorption into the…
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Added by John Robinson on October 19, 2017 at 6:07am —
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Today, we live in an era of customization. Increasingly, customers can modify a product’s appearance, features, or content according to their unique needs or desires. Often, even the news we see in our newsfeeds is customized based off our preferences.
Why, then, are so many aspects of the health care industry still one-size-fits-all?
As doctors, we’ve seen firsthand how this can negatively impact patients who require more individualized care. One particular example…
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Added by John Robinson on October 19, 2017 at 6:02am —
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The Statement on Standards for Accounting and Review Services (SSARS) is a section of the professional standards set out by The American Institute of CPA’s (AICPA), seeking to review earlier standards for reviewing and compiling financial statements and setting out the terms of engagement between the…
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Added by Adam Fleming on October 17, 2017 at 6:23am —
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Credit card surcharge was the bone of contention in an antitrust lawsuit filed 2005. As a result, the judgment in this case, which came in mid-2012, prohibited credit card surcharge in ten States. The implementation of their respective laws is underway in another 12 States.
Credit card regulations have traditionally opposed surcharging. Yet, companies have been devising ways by which they have sidestepped merchant rules and have continued to ensure that credit card surcharge gets…
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Added by Adam Fleming on October 16, 2017 at 6:13am —
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The market for medical devices in Japan is pretty huge. It ranks third in the world after the US and the EU. At just over $ 35 billion a year, which is characterized by an annual growth rate of 3-4 percent; it is far bigger than the markets in the neighborhood, such as China, Malaysia, Singapore and even Australia. Its market for medical devices is comparable to those of Europe and North America. Some of the reasons for this huge market are:
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Added by John Robinson on October 12, 2017 at 6:24am —
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Shares of drugmakers dropped in midday trading Friday after CNBC reported Amazon is in the final stages of considering an entrance into selling drug prescriptions.…
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Added by John Robinson on October 9, 2017 at 6:41am —
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Every year, millions of Americans go after this same goal, some successful and others not so much. To attain their goals, they may choose from the over-abundance of diets and exercise programs available, and some turn to weight loss supplements as well.
While you shouldn’t rely on supplements to do all the work for you, there are a few that can be used safely to boost your weight loss efforts.
Before you decide on weight loss…
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Added by John Robinson on October 9, 2017 at 6:36am —
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The basic reason for which analytical methods and procedures need to be validated is to ensure that analytical data have consistency, accuracy and reliability. This becomes possible when laboratories employ proper scientific methods and procedures and validate analytical methods and procedures. This is the only means to ensure that the analytical data are reliable, consistent and accurate.
The aim of doing so is to substantiate the suitability of…
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Added by John Robinson on October 4, 2017 at 6:49am —
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The basic reason for which analytical methods and procedures need to be validated is to ensure that analytical data have consistency, accuracy and reliability. This becomes possible when laboratories employ proper scientific methods and procedures and validate analytical methods and procedures. This is the only means to ensure that the analytical data are reliable, consistent and accurate.
The aim of doing so is to substantiate the suitability of…
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Added by John Robinson on October 4, 2017 at 6:48am —
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At present, home-based health care is gaining significant traction and poised for transformation. Once recognized as a fragmented and unorganised sector, it is gaining ground through progressively capturing interest of entrepreneurs and investors.
It is a known fact that there is tremendous pressure on hospitals in delivering services at their facility, especially in Critical Care, something that can be easily outsourced…
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Added by John Robinson on September 8, 2017 at 6:14am —
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The Occupational Safety and Health Administration (OSHA) today issued a Notice of Proposed Rulemaking to extend the employer’s responsibility to ensure crane operator competency and enforcement for crane operator certification to Nov. 10, 2018.
OSHA…
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Added by John Robinson on September 5, 2017 at 7:29am —
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With Obamacare firmly in the crosshairs of Republican lawmakers, the debate around U.S. healthcare is at a fever pitch.
While there is no shortage of opinions on the best route forward, the timeliness of the debate also gives us an interesting chance to dive into some of the numbers around healthcare – namely how people even get coverage in the first place.
How Americans get healthcare
The following infographic shows a breakdown of how…
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Added by John Robinson on August 9, 2017 at 5:59am —
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If you want to get the best health care, you might be better off living in one of these states, according to a new ranking.
Hawaii, Iowa and Minnesota topped WalletHub’s new ranking of the best states for health care. The ranking took into…
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Added by John Robinson on August 8, 2017 at 5:48am —
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Quality controls in laboratories are a major area for which the FDA issues 483’s. A laboratory is the venue for many activities, all of them of varying importance to the product. When controls in laboratories are not up to the standard, such a laboratory could produce products that do not meet quality and processes expectations, and hence invite 483’s.
Issues with drug quality, drug integrity and data integrity, as well as data fabrication and human errors…
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Added by Adam Fleming on August 8, 2017 at 5:36am —
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The Hazard Analysis and Critical Control Point (HACCP) is a process control system that is aimed at identifying the points or areas at which hazards (dangers) may arise in the food chain. It prescribes strict measures for manufacturers and transporters of food products to prevent contamination and the resultant hazards. Control of hazards in the food chain has always been a need, but HACCP assumes added significance in today’s…
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Added by Adam Fleming on August 4, 2017 at 5:31am —
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In any industry, compliance is everything; be it highly specialized fields such as the life sciences, healthcare, medical devices or non-technological areas such as food and clothing. Why do companies need to be compliant? It is simply because being in compliance with the required regulatory requirements helps the organization to achieve the most positive outcomes needed for a business:
- It earns them a good reputation
- Increases stakeholder and customer…
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Added by Adam Fleming on August 3, 2017 at 5:48am —
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The fact that medical device manufacturers work and operate in various regulatory systems whose requirements are different and not always consistent with each other is recognized and empathized by the…
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Added by John Robinson on July 21, 2017 at 5:56am —
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When people with autism spectrum disorder (ASD) –called just autism –enter college, they are up against challenges that are unique and peculiar to the group. They need to be understood for their special needs, because they enter college at a sensitive age. There is an onus on the part of the other people in the college, such as peer students and staff and those in…
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Added by Roger Steven on July 12, 2017 at 7:43am —
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