Don’t miss out! Offer @ $10 – Online Professional Courses

7This is a great deal. What else does one call this offer $10 deal to enhance professional skill from GlobalCompliancePanel? Wait. We are talking about $10, but did we tell you what you get for $10? Did you think it is the cost of registration for the event? Well, be prepared to get proven wrong –for the happiest of reasons. $10 is the price of a single recorded webinar that GlobalCompliancePanel is putting up at this great deal @$10 to enhance professional skills with GlobalCompliancePanel!

4Yes indeed, after all the rubbing of your eyes to confirm the truth of this seal, GlobalCompliancePanel assures you that it indeed has a great deal @$10 to enhance professional skills with GlobalCompliancePanel! Could regulatory trainings become more inexpensive and more affordable? Nowhere else in the market does one something of such high value as professional trainings in the regulatory compliance area for this price. Of course, a lot of items are available in the market for this price. Let us talk about a few toiletries. Let us talk about a few used books. Let us talk about some children’s clothing. But professional trainings that will take your profession as a regulatory compliance professional a few notches higher, at $10? Well, you can take your time to believe this, but it is true.

8This great deal @$10 to enhance professional skills with GlobalCompliancePanel is open to all professionals who want to enhance their skill and learning of the regulations in their respective domains of specialization. Who wouldn’t want to, at this price? When professional trainings in regulatory compliance becomes available at this great deal @$10 to enhance professional skills with GlobalCompliancePanel; what could be a better means to spend your ten dollars!

4What is the motive behind this offer? Simple: GlobalCompliancePanel has been a provider of professional trainings for the regulatory compliance arena for a good ten years now. It has become an established name in this area. It thought, why not make our trainings more wide-ranging and accessible to many more professionals? After all, regulations do keep changing every now and then. Shouldn’t regulatory professionals keep pace with them?

3A rich assortment of courses is available at this great deal @$10 to enhance professional skills with GlobalCompliancePanel. You can choose from trainings that help you with nuances of how to establish a reduce testing program for pharmaceutical and medical device components, where the guru of starting up, developing, implementing, managing, and remediating pharmaceutical and medical device Quality Systems, Howard Cooper, will show how to derive the benefits of systematic reduced testing program include increased compliance, smaller inventory cycles, less testing, less handling, and increased productivity and efficiency.

9Are you at odds when it comes to designing, planning and conducting effective audits? Then, why don’t you purchase this webinar that comes as part of great deal @$10 to enhance professional skills with GlobalCompliancePanel, in which Mark Roberts, Head of Roberts Consulting and Engineering (RCE), a consulting firm specializing in quality system and sterility assurance compliance, will offer his insights?

There could be no better means to improve your knowledge of regulatory requirements. And the time is now, with this great deal @$10 to enhance professional skills with GlobalCompliancePanel!

Contact Details:

https://www.globalcompliancepanel.com/webinars_home?wordpress-2017-SEO

John.robinson@globalcompliancepanel.com

Support@globalcompliancepanel.com

+1-800-447-9407

 

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:

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support@globalcompliancepanel.com

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Phone: +1-510-584-9661

Website: http://www.globalcompliancepanel.com

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Healthcare Compliance Professional Courses @ 10$ from GlobalCompliancePanel

globalcompliancepanel1.jpg

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

 

How Americans get their health insurance

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 Americans get healthcare coverage, based on information from Census Bureau’s surveys.

Put together by Axios, it shows the proportion of Americans getting coverage from employers, Medicaid, Medicare, non-group policies, and other public sources. The graphic also includes the 9% of the population that is uninsured, as well.

visual 1Axios via Visual Capitalist

The following definitions for each category above come from the Kaiser Family Foundation, a non-profit that uses the Census Bureau’s data to put together comprehensive estimates on healthcare in the country:

Employer-Based: Includes those covered by employer-sponsored coverage either through their own job or as a dependent in the same household.

Medicaid: Includes those covered by Medicaid, the Children’s Health Insurance Program (CHIP), and those who have both Medicaid and another type of coverage, such as dual eligibles who are also covered by Medicare.

Medicare: Includes those covered by Medicare, Medicare Advantage, and those who have Medicare and another type of non-Medicaid coverage where Medicare is the primary payer. Excludes those with Medicare Part A coverage only and those covered by Medicare and Medicaid (dual eligibles).

Other Public: Includes those covered under the military or Veterans Administration.

Non-Group: Includes individuals and families that purchased or are covered as a dependent by non-group insurance.

Uninsured: Includes those without health insurance and those who have coverage under the Indian Health Service only.

Healthcare mix by state

Here’s another look at how Americans get healthcare coverage on a state-by-state basis.

This time the graphic comes from Overflow Data and it simply shows the percent of buyers in each state that receive health coverage from public sources:

Oddly, the state that gets the highest proportion of public health coverage (New Mexico, 46.6%) is kitty-corner to the state with the lowest proportion of public health coverage (Utah, 21.3%).

Why the debate is paramount

If you ask some people what is going on with U.S. healthcare, they will tell you that things are going “sideways” – that costs are going up, but care is not improving anywhere near the same pace.

Here’s a graphic we published last year from Max Roser that puts this sentiment in perspective:

us healthcare systemVisual Capitalist via Our World in Data

It’s fair to say that care has been going sideways in the U.S. for some time, and the stakes couldn’t be higher.

So, what needs to be done to fix the problem?

Read the original article on Visual Capitalist. Get rich, visual content on business and investing for free at the Visual Capitalist website, or follow Visual Capitalist on TwitterFacebook, or LinkedIn for the latest. Copyright 2017. Follow Visual Capitalist on Twitter.

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

An integrated approach is needed for Complaints Handling, Adverse Event Reporting, and Recalls

Adverse Event Reporting, and Recalls4

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 new ISO version, the ISO 13485:2016. Because of the divergence in the requirements of each regulatory system; manufacturers are required to identify their roles, as well as the regulatory requirements for that role, and then incorporate them into their Quality Management System.

When it comes to post-market device issues; the various jurisdictions, however, deal with these in different ways. Three interlocking, interrelated processes need to go into the QMS:

  • Complaint management
  • Adverse event reporting
  • Recalls

Supporting QMS processes such as corrective action and design changes also need to complement these three processes. Over and above the QMS processes come the regulatory requirements, which usually involve areas such as recordkeeping and reporting.

A complete learning on how to implement an integrated QMS

Adverse Event Reporting, and Recalls3

A highly educative and valuable learning session on these primary and secondary QMS processes and the way they need to be understood and implemented vis-à-vis the US, EU, and Canadian regulations is being organized by GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance.

The Director of this two-day seminar is Dan O’Leary, who is President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, which focuses on analytic skills and a systems approach to operations management. Dan brings more than 30 years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs.

To understand the way in which to implement an integrated QMS in which the various aspects of complaints, adverse reporting and recalls are built; please register for this seminar by visiting An integrated approach is needed for Complaints Handling, Adverse Event Reporting, and Recalls This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Alignment with the FDA’s QMS is a major point

Complaints, Adverse Event Reporting, and Recalls - An Integrated Approach

One of the highlights of the final version of the ISO 13485:2016 standard, which has now become available, is the extent of its alignment with the FDA’s Quality Management System (QMS) requirement. Although the degree of alignment set out in 2016 version of 13485 is significantly higher than that of the previous version of 2003; there still do exist a few points at which it deviates from the FDA’s QMS. Companies that are required to comply with this standard have to keep this in mind.

Now that the ISO 13485:2016, the Medical Device Single Audit Program (MDSAP), and the new EU Medical Device Regulation have been introduced; companies need to update their QMS and integrate all of the elements if their implementation has to be effective and compliant. At this two-day session, Dan will provide the tools that the participants will need for this.

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The agenda of this learning session will be the following:

  • The Regulatory Structure
  • FDA QSR
  • ISO 13485:2016 and regional variants
  • ISO 14971:2007 and regional variants
  • Implementing MDSAP
  • The EU Medical Device Regulation
  • Servicing
  • Identification of problems
  • Servicing data analysis
  • Input to the complaint process
  • Complaints

Identifying complaints

  • Evaluating complaints
  • Investigating complaints
  • Complaint data analysis
  • Input to the corrective action process
  • Input to the risk management process
  • Corrective Action
  • Developing the process
  • Analyzing product and process information
  • Determining subsequent actions
  • Input to the design process
  • Input to the risk management process
  • Design and Design Changes
  • Determining the need for a design change
  • Documenting design changes
  • Design change verification and validation
  • Input to the risk management process
  • Input to the pre-market submission process
  • Risk Management
  • ISO 14971:2007 and regional variants
  • Incorporating post-market information
  • Updating Pre-market Submissions
  • US – The 510(k) guidance
  • EU – Technical files and design dossiers
  • Canada – License changes
  • Adverse Event Reporting
  • US – MDR
  • EU – Vigilance Reports
  • Canada – Mandatory Problem Reporting
  • Recalls
  • US – Corrections and Removals
  • EU – Field Safety Corrective Actions
  • Canada – Recall.

 

Do human factors matter in medical devices?

Do human factors matter in medical devices1

Is there a relationship between medical devices and human factors? This is a question that is seriously worth exploring. According to the ANSI/AAMI HE75:2009 document, human factors is an endeavor for optimizing the production of devices, systems, and many others concerned with them through the use of emotional, intellectual, physical and sensory forms of human knowledge. Both the ways in which these elements are used to enhance production, as well as the limitations inherent into them are factored in. In essence; human factors deal with how humans and devices or machines interact with each other.

Since human factors places the human mind at the center; design and aesthetics play a very prominent role in this discipline. Being an important element of user interface; human factors and user interface have risen in prominence after the explosion of the field of IT. It however, can be put into use in several other areas. The user being the fulcrum of any area of production; human factors has the potential to be a major factor in creating and shaping user interface for a range of products.

Use in medical devices

Do human factors matter in medical devices

How about the area of medical devices? We have seen that user interface and aesthetics are core ingredients of human factors. Are these the major determinants for the field of medical devices? Yes and no. Yes, because the user is of critical importance in medical devices. A wrong instruction or wrong usage can severely compromise the use of medical devices and can go the extent of even causing harm to the user.

No, because when it comes to another equally important element of human factors, namely aesthetics, the interplay between medical devices and human factors may not appear so pronounced. Yet, while role of aesthetics may not be all that critical to medical devices; there is a related aspect, and that is design.

The role of design is very prominent when it comes to the user interface of medical devices since medical devices have to be designed to absolutely precise specifications. Even small deviations or variations can result in harm to humans. Both the patient and the organization manufacturing the devices need to face consequences as a result of these.

As far as medical devices are concerned, the FDA is tasked with regulating them for ensuring their safety and effectiveness. The incorporation of the principles of human factors into medical devices ensures that the product meets specification, design and quality standards and thus becomes faster and less expensive to market. It is because of these factors that human factors are becoming part of the design and development, as well as of the supplementary aspects of medical devices, such as Instructions for Use, labeling and even training.

FDA’s regulations on human factors in medical devices

FDA_s regulations on human factors in medical devices

Under 21 CFR 820.30; the FDA emphasizes that human factors need to be taken into consideration for the following:

  • Design input: To ensure that the needs of the patient and any others who may use the product are taken into consideration

 

  • Design verification: To make sure that the criteria for performance set for the medical are being consistently met, and

 

  • Design validation: To safeguard that the device conform to predefined user needs as well as intended uses, and to also sure that testing is carried out to ensure this function. Software validation and risk analysis are part of this testing.

The FDA has also been placing emphasis on human factors in medical devices in many guidance documents and a number of upcoming Draft Guidance documents.

Full learning on human factors in medical devices

A seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance will offer complete learning on human factors in medical devices.

Virginia A. Lang, Principal and Founder HirLan, Inc. and HirLan International SA, will be the Director of this seminar. To gain knowledge of how human factors related to medical devices, please register for this seminar by visiting Do human factors matter in medical devices? This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A complete explanation of regulations and uses of human factors in medical devices

The core aim of this seminar is to familiarize participants with the way in which human factors can be applied into medical devices. Towards covering this, she will explain all the current and upcoming human factors requirements, using which, participants will learn how to keep costs under control and reduce the time for the manufacture and marketing of their products.

Virginia will cover the following areas at this seminar:

  • Overview of Human Factors and the FDA perspective
  • Human Factors Methods and Device Product Life Cycle
  • Human Factors and Risk Analysis & Management
  • Human Factors: What Devices Require Human Factors Evaluation and Validation?
  • Human Factors and Combination Products
  • Human Factors and Combination Products Submitted in an ANDA.