Teens also at risk for organ damage from high blood pressure

Teens also at risk for orga

And the damage to the heart and blood vessels can occur in youth at that are below the clinical definition of hypertension in youth.

High blood pressure in youth is defined differently than it is in adults. In childhood, high blood pressure is based on percentiles, rather than blood pressure level. Researchers looked at whether in teens develops below the 95th percentile, which is the clinical definition of in youth.

Researchers studied blood pressure and measured organ damage in 180 teenagers (14-17 years old, 64 percent white, 57 percent males). They found evidence of organ damage even among the youth categorized as “normal” with blood pressure less than in the 80th percentile. They also found heart and vessel damage in the mid-risk group, which had blood pressures in the 80th to 90th percentiles and the high-risk group, with blood pressures above the 90th percentile.

 

Read More: http://snip.ly/0v63t#https://medicalxpress.com/news/2017-09-teens-high-blood-pressure.html

All about Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems

All about Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems

 

Most pharmaceutical biofilms, especially those in water systems, suffer from one major flaw: misconceptions. Strict and rigid rules for design and operations, especially when they are built on ignorance, come in the way of proper implementation of effective water systems. When myths and hype surround these systems, it is but natural that they are doomed to failure.

Those in charge of pharmaceutical biofilms, more so those who deal with water systems need to be aware of all the aspects of water systems if they have to avoid failures. Lack of it can result in costly system downtime or even product recalls. It can result in costly system downtime or even product recalls.

All about Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems3

Pharmaceutical biofilms, especially those in water systems, thrive on fear and hype. No long term biofilm control can be achieved using a one-size-fits-all set of rules for design and operation. Biofilm can be controlled only when it is fully grasped. This is all the more important because each water system is unique. Water systems professionals need to get to the root of how biofilm grows into their system, which, obviously, would be quite different from any other system.

This is why those in water systems need to have proper insights into what actually lies behind some common water system designs. They need to clear the air about several misconceptions on the topic.

Solid understanding of water systems

It is to clear these myths and misconceptions that the world-acclaimed guru of water systems, Dr. Teri Soli, will be presiding over a seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance. T.C. Soli is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. (www.solipharmasol.com), and since becoming a full time consultant, has served consumer products and FDA-regulated industries with training and troubleshooting expertise. He has authored the complete rewrite of USP Chapter 1231, which many consider to be USP’s “pharmaceutical water bible”.

Want to understand the ways of implementing a water system that fulfils the conditions set out by the regulatory agencies? Just log on to All about Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems to enroll for this highly practical and useful seminar. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Learning on all aspects of water systems

In this microbiology-focused education about all aspects of water systems, Dr. Soli will offer knowledge of the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system.

This interesting and interactive session will give participants insights into what actually lies behind some common water system designs and will bust a few myths about the same. The learning imparted at this course will is translatable to any system, with the result that uneventful microbial control can be achieved. This is the foundation to effective operation and design. Without this understanding, participants will quickly find that blind rules for operation (and design) eventually fail to work, and the consequences of failure will far outweigh the educational costs that could have prevented it.

Knowledge of water system validation and Change Control

A good way to get understanding of this topic is to be familiar with water system validation and Change Control. This knowledge is necessary to help them come up with ways of improving outcomes and reducing the frequency of excursion investigations. Dr. Soli will offer understanding on this at this seminar.

Dr. Soli has set out the following agenda for this seminar:

  • What makes water systems have microbial quality problems
  • Successful sanitization approaches for trouble-free water quality
  • Water system validation by logic instead of tradition
  • Understanding and controlling endotoxin
  • Harmonizing vs optimizing water microbial testing for system quality control
  • Microbial enumeration issues with high purity water systems
  • Water system investigation “how to’s” and example case studies
  • What USP Does and Doesn’t Say about PW, WFI, Pure Steam and Micro Issues.

Congress, keep hands off employer sponsored plans in healthcare fights

Congress, keep hands

Lawmakers are back in town and soon the Senate Health, Education, Labor and Pensions (HELP) Committee will once again take up the beast that is healthcare.

Some will be tempted to merely throw more money and the semblance of flexibility into a broken system — we urge them  to reject this Band-Aid, and to instead implement real reforms. The ERISA Industry Committee (ERIC) implores Congress not to take this opportunity to protect the employer-sponsored health insurance system, which is the single most common source of health coverage in the nation, providing 178 million Americans with access to healthcare.

Congress is focused on stabilizing endangered exchange marketplaces. ERIC heartily agrees that market stabilization is important for everyone, but addressing the cost sharing reduction (CSR) payments to insurance companies is just a small part of solving the problem.

 

Last month, ERIC, along with several other organizations, sent a letter to Congress with policy recommendations that would help stabilize the market, while also ensuring the future of affordable employer-provided health benefits.

We recommended Congress should fund CSR payments to improve affordability in the individual market. Congress should also repeal the 40 percent “Cadillac” tax on employer-sponsored health plans, with no new taxes on health benefits. And lawmakers should repeal the health insurance tax on fully insured health plans, which a recent Oliver Wyman study found will cost Americans $22 billion next year alone. They should also enable employers to innovate with Health Savings Accounts (HSAs) and protect the ability of employers to offer uniform benefits to employees and their families — no matter where they live, work, or receive medical care.

Tax relief is key to protecting the employer-sponsored system. Since World War II, the American tax code has encouraged employers to set up quality health plans for their employees by exempting company health benefit expenditures from income and payroll taxes. The Affordable Care Act placed a crippling financial burden on plan sponsors through the employer mandate and the taxes mentioned above.

An easy place to start would be fully repealing the highly unpopular Cadillac tax. It has already been delayed until 2020 and lawmakers have voted to repeal it twice. The first time in 2015 and the most recent during the healthcare votes this past July.

The Cadillac tax will hit more than 50 percent of the workforce within ten years of its implementation, according to a January study by the consulting firm Milliman —that’s 60 million Americans. These employees could see their benefits slashed by thousands of dollar while their salaries stay flat.

Some economists theorize that because of the Cadillac tax, workers might see their pre-tax wages increase as employers switch to cheaper plans. But if that happens, employees would also pay a lot more in taxes, costing 12.1 million employees upwards of $1,000 in higher payroll and income taxes.

In fact, 80 percent of the revenue raised by the Cadillac tax is expected to come from workers paying more income and payroll taxes, according to the Joint Committee on Taxation and the Congressional Budget Office.

Aside from health tax relief, another way to improve the healthcare system is updating consumer-directed health options like Health Savings Accounts (HSAs). The Committee and Congress should raise HSA contribution limits, ensuring that HSA and high-deductible plan beneficiaries have access to supplemental benefits. They should also allow consumers to use their HSAs to purchase over-the-counter medicines while updating rules to ensure those enrolled in HSA-compatible plans can benefit from first-dollar coverage for prescription drugs and other medical products and services likely to prevent or reduce catastrophic episodes in the future.

The Senate HELP Committee must also look at value-based healthcare options, which are ways plan sponsors and consumers can spend healthcare dollars smarter. Earlier this year, The ERISA Industry Committee and the Pacific Business Group on Health launched the DRIVE Health Initiative, a campaign to accelerate economic growth by controlling health costs and improving quality through the rapid adoption of value-based healthcare. The initiative calls for targeted deregulation and the use of market-based purchasing strategies by Medicare and other federal health programs.

Fixing healthcare is not easy. As lawmakers move forward in crafting new legislation, they must be sure it protects the employer-sponsored system that has provided affordable, quality coverage to more than half of the population for decades and allow for continued improvement and innovations.

If they don’t, the employer-sponsored health insurance system could be in jeopardy, creating a much bigger problem than that of the ACA exchanges.

James Gelfand is the senior vice president for health policy at The ERISA Industry Committee (ERIC). ERIC is the only national association that advocates exclusively for large employers on health, retirement and compensation public policies at the federal, state and local levels.

Learn any professional courses for $10 only

GCP Offer 4

Want to enhance your regulatory compliance career by learning a new course? All that it costs is $10. Yes, GlobalCompliancePanel, a provider of professional trainings, is offering hundreds of high value regulatory compliance courses for a mere $10 each.

GCP offer 7

Regulatory compliance learning, that vital ingredient needed for professionals in any area of regulatory compliance, is a put off, because many professionals consider it expensive. But not anymore. GlobalCompliancePanel makes it possible to scale up in one’s career. What used to cost $265 is now available for $ 10, at about the price of a T-shirt. See the math: It is a saving of about 95%.

Myriad number of courses

GCp offer 9

Regulatory compliance, as we all know, is a really vast area of knowledge. With the FDA framing innumerable laws and regulations on every area that it regulates, it is imperative for regulatory professional to show compliance with the regulations. They are doomed if they fail. GlobalCompliancePanel brings hundreds of courses in all the areas of regulatory compliance to help professionals understand how to meet these stringent standards.

GCp offer 10

Want to explore what expectations the FDA has of the drug development process? Want to understand the nitty gritty of drug development and how to meet the FDA’s stringent requirements as far as IND and NDA requirements, or nonclinical or the human clinical studies required for it? Then, take a look at how GlobalCompliancePanel can help you achieve this, for just $10.

Are you working in an industry in which you are required to carry out Root Cause Analysis, but are having problems with it? Understand the fundamentals of Root Cause Analysis and get to know how to determine what caused the problem, why it happened, and what to do about it to reduce its likeliness of occurrence, with this course from GlobalCompliancePanel.

GCP offer 8

Have you understood how to get HACCP validation done for your facility? Do you have a problem in grasping its validation and verification? No worry. This recorded webinar from GlobalCompliancePanel will set you on the path to it. At just $10, it will offer you the knowledge you need for understanding how to tackle supplier and other issues and put in place a robust HACCP validation and verification program.

This is just a small sample of the many courses that are on offer for $10 each. Want to explore how many more courses are on offer at this huge discount price? Then, just visit our website to open up the possibility of unlimited learning. All that you need to spend is just $10 to enhance your learning on an area of regulatory compliance.

GCp offer 11

Contact US:

NetZealous LLC DBA GlobalCompliancePanel

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support@globalcompliancepanel.com

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

Website: http://www.globalcompliancepanel.com

Registration Link –

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Healthcare Compliance Professional Courses @ 10$ from GlobalCompliancePanel

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Healthcare professionals now have a stronger reason than ever before to enroll for professional learning courses and upgrade their knowledge. GlobalCompliancePanel, a highly reputable provider of professional trainings for all the areas of regulatory compliance, will offer a pick of their healthcare compliance courses for just $10.

Healthcare professionals have always been flocking to GlobalCompliancePanel to partake of professional trainings courses that are valuable, relevant and highly interesting. They will now have more reasons for doing so and join thousands of healthcare regulatory professionals who have already benefited from GlobalCompliancePanel’s professional trainings, because it is not every day that one comes across an offer in which the professional gets to pay a mere 5% of the original price of the webinars!

These recorded webinars are on a number of topics concerning healthcare. Healthcare professionals can use these courses to augment the learning they have gained over the years and climb up in their professions with even greater ease. What’s more; healthcare professionals have such a huge number and variety of courses to choose from that they can opt for several courses of relevance to them without burning a hole in the pocket.

Why is GlobalCompliancePanel doing this? Simple: It wants more and more healthcare professionals to take up courses that are relevant and valuable to them, so that the knowledge needed for becoming successful in their careers spreads wider and goes deeper. After all, meeting regulatory compliance requirements is the number one challenge for any healthcare professional, who sees no way out of the regulatory maze without the professional trainings needed to understand them. When such a course is available at a throwaway price of $10, isn’t that a delightful thing to have?

Let us feature a couple of the topics on which GlobalCompliancePanel is offering these courses to healthcare regulatory professionals:

The HITECH Acts Impact on HIPAA

HIPAA enforcement is a matter of serious concern to many healthcare professionals. Many of them, even highly experienced ones, are clueless about some of the aspects of this enigmatic law. When HITECH combines with HIPAA; the confusion is doubled. The two laws intersect at many places, thus compounding the complexity of enforcement. This webinar from GlobalCompliancePanel offers clarity and helps them ease the confusion about this law.

Further, the nature and roles of a host of HIPAA-related items such as breach notification, business associate contracts, training of staff and security of PHI for Business Associates can be daunting to understand and implement. Webinars such as this are designed to help healthcare professionals steer clear of the stumbling blocks that they could encounter in implementing these.

Preparing a Medical Product Regulatory Requirement Plan

What happens when healthcare companies fail to meet regulatory requirements set out by the FDA and other regulatory agencies? The consequences are disastrous, and can range from penalties to having their business shut down. One of the foundations to avoiding this sort of situation is to develop a medical product regulatory requirement plan.

A medical product regulatory requirement plan charts out the regulatory requirements  that need to be met from step one, which is quite literally Day One of the start of the process of making healthcare products. A detailed and organized medical product regulatory requirement plan is indispensable to ensuring in the end that the healthcare product meets the regulatory requirements.

It is this priceless learning that this webinar from GlobalCompliancePanel imparts. And yes, at $10!

Drug Safety and Pharmacovigilance

Pharmacovigilance, a crucial area of healthcare, needs to be implemented in full according to the requirements set out in regulations from the FDA, EMA and other regulatory agencies. Drug safety being deeply tied to PV; the proper implementation of the latter is needed to ensure the former.

PV is essentially about ensuring drug safety by implementing measures throughout the process of production. A healthcare company has to comply with directions from a number of regulatory agencies in order to have its products passed by them and to gain permission to enter different markets. They cannot afford to take one wrong step in the whole process. A number of areas such as clinical trials, marketing, disease management and government are just some of the areas in which pharmacovigilance is indispensable.

This webinar from GlobalCompliancePanel is a great means to getting a complete understanding of this intricate topic. The topic is of great relevance to healthcare professionals, but what’s more; it comes at this unbelievable price tag of just $10!

Contact Details:

http://www.globalcompliancepanel.com/webinars_home

John.robinson@globalcompliancepanel.com

Support@globalcompliancepanel.com

+1-800-447-9407

 

Health Buzz: The 10 Best States for Health Care

 

Health Buzz The 10 Best States for Health CareIf 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 account 35 metrics in the categories of cost, accessibility and health outcomes.

Among access-to-care metrics, the highest percent of insured adults (ages 18 to 64) live in Massachusetts, the District of Columbia, Vermont, Hawaii and Minnesota. The lowest live in Georgia, New Mexico, Nevada, Florida and Texas.

As for outcome metrics, like lowest cancer rate, New Mexico, Nevada, Arizona, Colorado and Utah ranked in the top five, while New York, Pennsylvania, Louisiana, Delaware and Kentucky ranked in the bottom five.

U.S. News ranks its own Best States for Health Care, in which Hawaii also stands at No. 1.

Health care concerns, though always present, have been thrust into the national conversation even more this year amid legislative attempts to reform former President Barack Obama’s health care law.

The Senate recently failed to pass a health care bill. Sens. Susan Collins (R-Maine), Lisa Murkowski (R-Alaska) and John McCain (R-Ariz.) voted against the Republicans’ attempt to overhaul the Affordable Care Act, commonly known as Obamacare.

A recent report from the Commonwealth Fund found that the U.S. has the worst health care system compared to other high-income countries. The U.S. ranked lowest for health outcomes despite outspending its peers, according to the report.

But in its own health care analysis, the Kaiser Family Foundation discovered the U.S. system has made progress, especially with “its ability to promote health and provide high-quality care, with some recent improvement in the accessibility of that care and a slowing of spending growth.”

Americans typically spend approximately $10,000 each year on personal health care, and that number is expected to rise, according to the Centers for Medicare & Medicaid Services.

WalletHub’s top 10 states for health care are listed below, and a complete list can be found here.

Overall Rank State ‘Outcomes’ Rank
1 Hawaii 1
2 Iowa 13
2 Minnesota 8
4 New Hampshire 7
5 District of Columbia 37
6 Connecticut 5
7 South Dakota 24
8 Vermont 3
9 Massachusetts 2
10 Rhode Island 10

It is important and necessary to document Software for FDA Submissions

It is important and necessary to document Software for FDA Submissions2Software project management has an important tool in the Agile methodology. The Agile methodology developed as a product of the gradual efforts at arriving at a team based methodology of iterative software development. Because of its close association with software, in terms of suitability; Agile is to software development what Lean is to manufacturing. Among the many areas in which the Agile methodology is very well suitable and adaptable; healthcare is one, since it uses software heavily.

The Agile methodology is effective in helping software project managers anticipate and address major logjams of software project management, such as vulnerability and unpredictability. By preventing project delays; Agile helps to cut costs. Since flexibility is an important characteristic of Agile; it has the ability to accommodate and take in many new changes that take place as the project develops.

Another major benefit of Agile is that it prevents piling of work at later stages of the project by reviewing project progress at every stage by validating roles, steps and processes functions. This is absolutely useful in the backdrop of severe constraints of time and money, because of which it is highly preferred and rated by Project Managers.

Is Agile perfect?

Judge_Phone

All these terrific advantages notwithstanding; Agile is not perfect. It is not suited in every setting and in every situation. If Agile has to be efficient and deliver its results optimally; it has to work in conditions where there is complete, tightly knit team coordination. In the absence of very active and strong participation from the team leaders, subject matter experts and stakeholders; Agile can prove less than suitable or successful.

Agile’s suitability for the healthcare industry is well-established. However, Agile, being a highly teamwork-dependent initiative can fail to deliver in the absence of one or more situations in which it thrives. In the absence of complete confidence by those using it in the healthcare industry of its role in saving money, time and other resources; the Agile methodology can be less than useful

Get to learn the applicability of Agile methodology to healthcare

Business.

The ways by which the healthcare industry can adapt and optimize Agile methodology for its use and overcome the deficiencies and shortfalls of this methodology for enhanced performance will be the topic of a very interesting two-day seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance.

The Director of this seminar is Brian Shoemaker, who consults for healthcare products companies on computer system validation, software quality assurance, and electronic records and signatures, and has worked with companies in Germany and Switzerland as well as the U.S. Please register for this session by logging on to It is important and necessary to document Software for FDA Submissions. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Clarity on the suitability of Agile to IEC 62304

It is important and necessary to document Software for FDA Submissions3

A criticism that does the rounds in healthcare software industry circles is that Agile, because of its lack of documentation, runs counter to the lifecycle standards mandated in IEC 62304. Brian will clarify on this area and explain how clear processes for quality management system, risk management process, software maintenance, configuration management, and problem resolution, which go into the IEC 62304 principles actually reinforce, rather than undermine the Agile methodology. The proof of this fact is that the AAMI Agile report (TIR 45) has stated that the proper application of Agile, with its emphasis on nimbleness and ongoing learning, into a quality system and safety risk management can blend with and expedite the fulfilment of regulatory expectations of well-documented development.

Contrary for popular belief, documentation in Agile actually helps in taking advantage of iterative development. How? Since the IEC 62304 does not specify any lifecycle model; documentation can grow out of the required iterative activities. Agile, by developing incrementally and preventing last minute anxieties and worries; is highly useful in many disciplines of healthcare such as hazard analysis. When risk management is included in iteration tasks; it becomes more robust and solid.

It is because of all these reasons that this is a session that professionals across a wide spectrum of positions such as Regulatory Specialists, Quality Assurance Specialists, Documentation Specialists, Test Managers, Software Team Leaders and Lead Developers, and Project and Program Managers ought not to miss out on.

They will get thoroughly familiarized on the applicability of the Agile methodology to software documentation for FDA submissions. Over these two days of this seminar, Brian will cover the following areas:

  • Agile vs IEC 62304: an apparent contradiction?
  • The role and value of documentation
  • The REAL regulatory requirements
  • Specific documents required for an FDA submission
  • Areas where most development processes bog down
  • Iteration – well suited for risk, usability, and design reviews
  • Key practices to bridge the Agile and regulated worlds
  • Agile is not only acceptable for medical device software, but can be clearly superior.