How to Find the Right “DIETARY SUPPLEMENTS” for Your Specific Product (Service)

These have to match what is specified in the master manufacturing record.

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Compliance4All, a leading provider of professional training for all areas of regulatory compliance, is organizing a 90-minute webinar on the topic, “Dietary Supplements CGMPS – 21 CFR 111 Compliance”, on February 5. John E. Lincoln, a medical device and Regulatory Affairs consultant, will be the expert at this webinar.

Please visit http://bit.ly/2DIk8lf to enroll for this webinar.

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How to find the right dietary supplements for your specific product (service) can be quite a challenge, if you are one of the players in the industry. The reason is this: manufacturers, labelers and packagers of dietary supplements, and even those who hold them, have to comply with the requirements set out in 21 CFR Part 111.

21 CFR Part 111, or what is called the “DS CGMP rule”, requires those who manufacture, package, label and stock dietary supplements to ensure the quality of the product by adhering strictly to the packaging and labeling requirements set out in this Part. These have to match what is specified in the master manufacturing record.

Till the FDA published the Dietary Supplements CGMPs as a “Final Rule”, which brought 21 CFR 111 into existence, the Quality Management Systems and controls on dietary supplements were loose and voluntary in nature. About the only requirement was the one set out by the Dietary Supplement Health and Education Act of 1994 (DSHEA), by which the Congress defined what is meant by a “dietary supplement”, and only required that every supplement be labeled a dietary supplement.

Complying with 21 CFR 111 is not optional

All that has changed with 21 CFR 111. To start with, the FDA now has a set of regulations for dietary supplements that is different from what is set out for conventional foods and drug products.  And then, players in the dietary supplements field that fail to comply with these requirements can have their products termed “adulterated” or “misbranded” by the FDA.

Despite the introduction of this Part, considerable confusion abounds in the industry as to just what type of manufacturing controls and record keeping, and labeling content the FDA requires, with the result that this Part continues to be a regulatory sore point for many new and established companies in the industry.

It is this confusion that this webinar seeks to clarify. John E. Lincoln will help participants of this session resolve these issues.

John will explain all the aspects of FDA Part 111, which will include Quality Management System/Quality Assurance/Quality Controls, personnel, facilities, equipment, software controls, production and Process Controls, holding and distribution, complaints and returns, and records.

At this 90-minute webinar, which is aimed at benefiting Senior Management in the dietary supplements industry, QA/RA, R&D, Consultants, those in Engineering and Marketing, those tasked with Product, Process, Validations and CGMP responsibilities, as well as other interested consumer groups, medical and other healthcare professionals, staff and office personnel, and start-ups, John will cover the following areas:

  • History of Dietary Supplement regulation in the U.S
  • The Dietary Supplement Health and Education Act (DSHEA)
  • The key requirements of the Dietary Supplements CGMPs, 21 CFR 111
  • Required steps for CGMP compliance
  • Problem areas, common pitfalls
  • Implementation: Systems, templates and tools.

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About the speaker:

John E. Lincoln is a graduate of UCLA. His experience also includes managing pilot production, regulatory affairs, product development/design control, 510(K) submissions, risk management per ISO 14971, and projects. He brings over 28 years of experience in the FDA-regulated medical products industry, during which he has worked with companies ranging from startups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt.

Health IT C-suite to become [organizational] leaders

The CIO is now needed from the standpoint of strategy development because he or she is affecting the entire organization.

The healthcare CIO is the correct initialism for “chief information officer,” but as the landscape continues to shift—with the focus now on digital and strategic optimization, transformation and innovation—some observers are now wondering if “information” is really the most appropriate word for all that encompasses the modern-day CIO.

For the past two decades, Chuck Podesta has been a healthcare CIO, spending the last four years at UC Irvine Health, the integrated health system at the University of California-Irvine in Orange County, California. Podesta recalls the days when the CIO had a more IT-based title and financially-related job in healthcare, since clinical IT wasn’t a strong focus at that time. But with the evolution of EHRs (electronic health records), says Podesta, “The focus became clinical and the job suddenly had a broader scope. It’s not just the day-to-day running of the systems anymore; the CIO is now needed from the standpoint of strategy development because he or she is affecting the entire organization.”

Electronic-Health-Records

Some would refer to the early-day healthcare CIO as an IT engineer of sorts, someone very technology-focused whose core responsibilities centered around hardware and software implementations, and getting servers up-and-running within the organization. Then came the influx of EHR deployments across hospitals and health systems, and now that there is near-universal possession of EHRs in U.S. hospitals, the tide is once again shifting.

“In the past, the CIO had more of a technical role and the focus was more on the operational side of the house—things such as enterprise resource planning (ERP) and the billing cycle. But the widespread advent of EHRs changed so much of that,” says Dave Levin, M.D., a former chief medical information officer (CMIO) at Cleveland Clinic and current chief medical officer at health technology company Sansoro Health. “When you deployed the EHR, it tightly linked clinical operations to IT. And that’s obvious. But it also put IT in the middle of enabling all kinds of activities and strategies. So, this requires strong enterprise governance and strong IT governance, and it requires that they fit together. A lot of organizations are struggling with that, and that’s reflected in the role the CIO plays,” Levin says.

Podesta notes that when the CIO title first came about, many directors of IT in healthcare organizations wanted the “chief” designation. But to Podesta, there was a key difference between IT directors and CIOs: good directors of IT spend 80 percent of their time managing day-to-day operations and 20 percent of their time on strategy, but for “true” CIOs, it’s the opposite, he says. “There was a period where there was a ‘filtering out’ of individuals who tried to become CIOs, but were really IT directors and couldn’t make that leap into the strategy world. That led to a changing of the guard,” he says, adding that much of the new focus turned to developing EHRs and then becoming an equal player in the C-suite on the strategy teams. “You have to be able to work on IT strategy and develop it in conjunction with the business strategy,” Podesta attests.

Today’s CIO – One of the Scariest Jobs in Healthcare?

How Can [Gigantic] knowledge energy the future of Healthcare

Big data can be used to reduce human errors. The analysis can be used to scan a patient’s history of medical records and identify potential errors and flag anything that seems out of place.

In today’s world, the usage of big data has made huge leaps in in various industries, healthcare is no exception. Being one of the largest industries in the U.S., big data is already used in various sectors for predictive and analytic reasons. Big data can help and challenge scientists to create and analyze data in ways it has ever been done before.

In this article, I’ll explain how big data has already been adopted in some areas but I’ll also take a look into the future and give some insight in the ways with great potential in which big data can be use to push forward the healthcare industry.

Fitness Industry Connects with Healthcare

The fitness industry has become one of the most progressive parties in adopting big data, especially for wearable fitness technologies. Generally speaking, fitness tracker gadgets encourage people to exercise more and keep track of the results.

Two of the biggest companies in this area are Fitbit and Apple Watch. The gadget’s software tracks the user’s day-to-day activities, exercise sessions, sleep, nutrition and body weight.

Features-Offered-by-IoT-for-the-Healthcare-Industry

The software is tracking all these data points from millions of users which is then used to analyze the data and link it to health and various other things.

So, how can this data be linked to the healthcare industry?

Obviously, the data isn’t 100% reliable and it would probably not affect the healthcare industry directly. But you can’t deny that such large data sets, that track and store human data on a daily basis, are very helpful and can have a significant impact on healthcare in the future. At the moment, it’s one of the biggest sources of personal health-related and real-time data.

For example, prevention is an important aspect of healthcare as governments and health institutions work tirelessly on new ways to prevent certain diseases and other health-related issues.

That being said, critics voiced a lot of negative feedback in regards to privacy-related matters. This is largely based on a report published by the Federal Trade Commission, which claimed that based on an analysis of ~10 fitness applications, 76 third parties received personal data generated by these fitness trackers – most likely bought.

In the future, the data will probably be more accurate as the technology to track the earlier mentioned data points will improve massively.

Healthcares- Big data

Reducing Costs

Big data is also a great solution to calculate current business models, cost models and expenses. It’s therefore extremely valuable for healthcare institutions to analyze their current situation based on big data to save costs.

Additionally, data sets can be analyzed and models can be built in order to predict staff allocation and other rates based on historical data that clearly shows when it’s busy. For example, during winter holidays there’s a higher chance for ski – or snowboarding accidents than in the summer.

Thus, health institutions can that money and allocate it to new investments such as equipment or research. It’s also linked to insurance companies, which save money if the allocation of staff, hospital beds and so on is better utilized.

Prevent Medical Human Errors

Medication prescription errors are a serious problem for hospitals and other healthcare institutions. Everyone is still human, so there’s always a chance to make a mistake by prescribing the wrong or different medication accidentally. In worst case scenarios, it may actually harm the patient with potentially a catastrophic ending.

Big data can be used to reduce human errors. The analysis can be used to scan a patient’s history of medical records and identify potential errors and flag anything that seems out of place.

Especially healthcare professionals who cater a lot of patients throughout the day risk a higher chance of making a mistake. Thus, software to help them out would be the perfect solution.

A high-end research paper “Harvard Research Shows New Technology Can Save Thousands of Lives a Year by Reducing Prescription Errors” stated that from almost 800,000 analyzed patients, little under 16,000 errors were flagged and 75% of these red-flags were actually validated.

The report also states that U.S. healthcare loses around $20bn is lost per year, as a result of prescription errors.

The only downside of this newly developed algorithm is that many hospitals and other healthcare institutions still work with relatively old computers, probably not capable of running such a memory-heavy software tool.

How much changes here it happens don’t miss http://bit.ly/2w2DUDX

Which eliminates a patients [restrictions] with medical consultants

Healthcare IT is much more than just an electronic version of paper medical records.

Evaluation–Diagnose–Treatment. This is the traditional and generally accepted method ofa medical procedure. However, the healthcare sector has evolved over the last couple of years. Today’s healthcare is using a new, digital companion to determine how patients feel based on much more than their present medical condition. Healthcare information technology or healthcare IT is widely used by doctors, surgeons, and pharmacists to understand medical information of patients and improve communication between doctors and patients.

What Is the Use of Healthcare IT?
The major advantage of the healthcare IT is that it reduces the communication gap between a patient and doctor as the healthcare IT collects and converts the patient’s information from paper records and medical charts to electronic data.This migration provides direct access to patient’s information to doctors irrespective of their location and enables to share knowledge with other doctors than the current medication providers. Moreover, the doctor-recommended prescriptions can be transmitted electronically owing to the healthcare IT, which has improved efficiency and reduced the valuable time.

Healthcare IT is much more than just an electronic version of paper medical records. It includes previous maintained medical images by radiology departments and opinions of specialists on a certain method of treatment. In addition, the digital messages including emails,healthcare tips, chat logs, the day-to-day medical progress of a patient, and financial factors such as scheduling and billing fall under the sky of healthcare IT. However, these records must be stored and maintained carefully to prevent invasion of privacy. On the other hand, the technological advancements and easily accessible facilities fuel the demand for healthcare IT.

Roughly, two-third Americans have instant access to the internet, which eliminates a patient’s restrictions with medical consultants.The tech giants such as Microsoft, Apple, and other new startups are developing up-to-the-minute opportunities in the healthcare IT market by improving access to digital applications and providing efficient security features. This has increased demand for healthcare IT services, boosting the growth of the healthcare information technology market. According to a report published by Allied Market Research, the market is expected to register a CAGR of 13.2 % in the period 2014–2022.

Healthcare IT Generates Job Opportunities
The growth of healthcare IT has created a surge in job opportunities in IT sector. According to the U.S. Bureau of Labor Statistics, by the end of 2024, the need for healthcare and medical managers will boost by about 17 percent.

Therefore, coding experts are extremely essential to smoothly transfer the individual records of patients to a central hub, by changing the codes that could otherwise interrupt the transfer of information. It is estimated that the requirement of such new codes is nearly 130,000. Moreover, the IT specialists assist healthcare service providers to obey the federal guidelines for records, a collection of data and share to protect a patient’s privacy. Due to such requirements, there are ample of IT companies and even startups that are launching new platforms to develop a sustainable healthcare IT department.

Recently, JavaraInc., a clinical research service organization, launched a platform that is focused on compelling innovative research partnerships, service,and technology to healthcare systems. Jennifer Byrne, the co-founder,and CEO of Javara stated that the new healthcare IT platform will bring better outcomes for patient-centered care, better economic results, and easier research delivery model to the bio pharmaceutical sector.

http://bit.ly/2JPFMnC

Why it’s good for your health to be outdoors

Referencing a study where students who spent time in the forest had lower levels of inflammation than those who spent time in the city.

Sure, there are treadmills at climate-controlled gyms and Nintendo’s Wii is still going strong with indoor workouts like Zumba Fitness 2.

And yet, old-fashioned advice to “go outside and play” is still the best for your health, according to researchers the world over. In one study published by the NCBI, researchers found a decrease in both heart rate and cortisol levels when participants spent time in the forest instead of the city.

“Stressful states can be relieved by forest therapy,” the researchers concluded.

The encouragement to “get outdoors” for health holds even in the face of the Asthma and Allergy Foundation of America’s assertion that pollen seasons have gotten stronger and longer over the years. The workaround: the AAFA recommended limiting outdoor activities, but only on days when pollen is high for the trees or grasses you are allergic to.

Being outside delivers other health rewards, too, from sharp mental health benefits to improved memory and decreased inflammation.

Here are four of the most significant health benefits from spending time outdoors, according to Business Insider:

Walking in the woods can improve your short-term memory.

“Nature walks have memory-promoting effects that other walks don’t,” BI noted, citing a study where participants who walked among trees did 20 percent better on a memory test than those who had taken in city sights.

Outdoor experiences can fight depression and anxiety.

Time in nature may combat depression, anxiety and other mental health issues, especially when combined with exercise.

One study associated walks in the forest with decreased levels of anxiety and bad moods while another found outdoor walks could be “useful clinically as a supplement to existing treatments” for major depressive disorder, BI reported.

Being outdoors has a demonstrated de-stressing effect.

One study published by NCBI found that students sent into the forest for two nights had lower levels of the stress marker cortisol than those who spent that time in a city.

Spending time outside reduces inflammation.

Inflammation in overdrive is associated with ills that include autoimmune disorders, inflammatory bowel disease, depression and cancer. “Spending time in nature may be one way to help keep that in check,” BI noted, referencing a study where students who spent time in the forest had lower levels of inflammation than those who spent time in the city.

More at https://on-ajc.com/2uDKqPT

Point-of-care ultrasound: a reliable bedrock of the general hospital

Medical scope of practice can vary by state, country and/or local jurisdiction.

Point-of-care ultrasound is at the heart of Frimley Park Hospital’s anaesthesia department, guiding procedures such as vascular access and nerve blocks. Dr Tim Pepall, a consultant anaesthetist at Frimley Park, explained: “It’s essential to use ultrasound for central vascular access because of NICE guidelines, but we also use it occasionally for difficult peripheral vascular access and arterial lines.

Ultrasound has transformed regional anaesthetic practice and we were relatively early adopters of it – it made sense to see the nerves, rather than going in blind. There is so much variation in nerve and vascular anatomy that you realise your previous techniques were really feeling in the dark. Nowadays, I would be very reluctant to do a plexus block without an ultrasound machine.”

Tim continued: “We’ve been using FUJIFILM SonoSite point-of-care systems for the last 10 years. There are five SonoSite instruments in the anaesthetic department and we’ve stayed with the one manufacturer because we’ve been very happy with it – we like the back-up service, as well as the simplicity of the systems and the quality of images it provides.

The SonoSite S-Nerve interface is very intuitive, and it is great for portability, we can transfer it onto the wards and take it wherever we need to use ultrasound. With the new SonoSite X­Porte, we’re also doing more echocardiography than before – which saves us having to discuss preoperative cases with the cardiologists as often – and we can see dynamic changes as they occur, and responses to our interventions.”

SonoSite, the SonoSite logo, S-Nerve and X-Porte are trademarks and registered trademarks of FUJIFILM SonoSite, Inc. in various jurisdictions. FUJIFILM is a trademark and registered trademark of FUJIFILM Corporation in various jurisdictions. All other trademarks are the property of their respective owners. Copyright (c) 2018 FUJIFILM SonoSite, Inc. All rights reserved. Subject to change.

Medical scope of practice can vary by state, country and/or local jurisdiction.

FUJIFILM SonoSite, Inc., is the innovator and world leader in bedside and point-of-care ultrasound, and an industry leader in ultra high-frequency micro-ultrasound technology. Headquartered near Seattle, the company is represented by a global distribution network in over 100 countries. SonoSite’s portable, compact systems are expanding the use of ultrasound across the clinical spectrum by cost-effectively bringing high-performance ultrasound to the point of patient care.

Many young people still do not have a positive experience

The investigation was sparked by the suicide of an 18-year-old shortly after moving from child to adult mental health services.

The Healthcare Safety Investigation Branch (HSIB) said many young people experienced a difficult transition from child to adult care at exactly the time when they were most vulnerable.

Its report recommended a more flexible approach to moving into adult services instead of having the cut-off at 18.

Every year 25,000 make this transition.

But as adult services often have different thresholds for providing support, delays can happen or young people can lose their support altogether.

The HSIB — a new body set up to carry out no-blame investigations to help the NHS learn from mistakes — recommended a wider window so transition could take place gradually up to the age of 25.

The investigation was sparked by the suicide of an 18-year-old shortly after moving from child to adult mental health services.

It said the young man had been let down, with his child mental health service hampered by the pressure to pass him on to adult care.

The findings have been backed by those who have experienced the system.

‘Life on adult ward was scary’

Tee spent two years in a mental health hospital in Northampton when her transition from child to adult services went wrong.

She was self-harming when she was young and started getting help when she was 14.

Within three years, the process of moving to adult care began.

But there was a year delay before she got help, by which point she had to be admitted under the Mental Health Act after taking an overdose.

She describes her time on an adult ward as “very scary”.

More at https://bbc.in/2zlWFX3