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?

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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.

 

 

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.

 

 

 

Seminar Calendar of Upcoming Courses – June to July – 2017

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GlobalCompliancePanel’s seminars are a wonderful opportunity for professionals in the regulatory compliance areas to understand the latest happenings and updates in the regulatory compliance areas and to implement them, something they need to climb in their professions. GlobalCompliancePanel brings together a few of the best recognized names in the field of regulatory compliance on its panel of experts. The result: Learning that is effective, valuable and helpful.

GlobalCompliancePanel’s experts help you unravel all the knowledge you need in all the areas of regulatory compliance. At these seminars which are held all over the globe, you get to interact with them in person, so that any doubt or clarification you have is sorted out by none other than the honcho. They help professionals like you implement the regulations and stay updated, so that regulatory compliance causes no stress for you.

GlobalCompliancePanel’s experts offer their insightful analysis into the issues that are of consequence to regulatory professionals in their daily work. Their thoughts help you implement the best practices of the industry into your work. They also offer updates on the latest regulatory requirements arising out of a host of the laws and issues related to regulatory compliance, including, but not limited to medical devices, food and beverages, pharmaceuticals, life sciences, biotechnology and pharmaceutical water systems.

Take a look at our upcoming webinars from GlobalCompliancePanel, which will put you on the road to learning about any area that is of importance to your profession. You can plan your learning from GlobalCompliancePanel by looking at our seminars in the next few weeks at locations of convenience to you. You can choose from a whole range of topics. See which among these trainings suit you: Design of Experiments (DOE) for Process Development and Validation, Writing and implementing effective SOP’s, new FSMA rules, risk management and device regulations, data integrity, combination products, and what have you!

Contact us today!
NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
Toll free: +1-800-447-9407
FAX : 302 288 6884
Website: http://bit.ly/Courses-June-to-July-2017

GlobalCompliancePanel announces Seasonal offers for Professionals with Flat 50% OFF on all Seminars

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Do celebrations need a cause and a reason? Yes, and GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, is having a solid cause and reason for doing so. It is celebrating the many years of its relationship with its customers spread all over the world by offering its trainings at a massive 50% discount!

Yes, that is right. GlobalCompliancePanel’s seminars will be available for a huge 50% discount till April 30. Regulatory professionals who want to augment their knowledge of regulatory compliance can now do so by paying just half the price of these trainings from GlobalCompliancePanel. All that is needed to do walk away with a rare offer such as this is to visit https://www.globalcompliancepanel.com/seminar?wordpress_SEO and use MGCP50 Promo Code.

This offer is valid till April 30, 2017. Regulatory professionals who want to take any of GlobalCompliancePanel’s trainings can book their trainings for an area of their interest by this date. From April 1 onwards, this offer will cease, meaning that the original price will apply from then.

So, why is GlobalCompliancePanel offering this discount? It is for a simple, but profound reason: It wants to thank its huge customer base for the support they have been extending to this company over the many years for which it has been in business. During the course of the 10 years for which GlobalCompliancePanel has been in business, it has trained thousands of regulatory compliance professionals from around the world.

These professionals, belonging to such varied geographies as the US and Japan and India and Canada, have been able to meet their regulatory compliance challenges on account of these trainings. These trainings are relevant, focused and valuable, and are from some of the best known regulatory compliance Experts found anywhere on this planet.

It is these trainings that have been hoping these professionals in the regulatory compliance arena gain more insights into regulations from the FDA, the EMA and other such bodies around the world. These trainings have been consistently helping them to meet these challenges, as they give them a better and sharper understanding of the implementing these requirements.

These regulatory requirements can pose hurdles to the most experienced and brightest of regulatory compliance professionals in the medical devices, pharmaceutical, life sciences and food and biologicals areas, but not to those who undertake professional trainings from GlobalCompliancePanel. GlobalCompliancePanel’s panel of experts is here to help them overcome these challenges and hurdles.

This trend has been being witnessed from the time GlobalCompliancePanel entered the line of professional trainings. Any wonder then, that no fewer than 50,000 professionals have benefited from these trainings? What could be a better way of thanking such a huge base of customers than with this offer? GlobalCompliancePanel believes that a celebration should also be useful, and this is that this offer is!

Hurry up and enroll today. Happy learning!

 

 

GlobalCompliancePanel Professional Training and Development Courses with Flat 50% OFF on all Seminars

Do celebrations need a cause and a reason? Yes, and GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, is having a solid cause and reason for doing so. It is celebrating the many years of its relationship with its customers spread all over the world by offering its trainings at a massive 50% discount!

Yes, that is right. GlobalCompliancePanel’s seminars will be available for a huge 50% discount till March 31. Regulatory professionals who want to augment their knowledge of regulatory compliance can now do so by paying just half the price of these trainings from GlobalCompliancePanel. All that is needed to do walk away with a rare offer such as this is to visit http://www.globalcompliancepanel.com/ and use MGCP50 Promo Code.

This offer is valid till March 31, 2017. Regulatory professionals who want to take any of GlobalCompliancePanel’s trainings can book their trainings for an area of their interest by this date. From April 1 onwards, this offer will cease, meaning that the original price will apply from then.

So, why is GlobalCompliancePanel offering this discount? It is for a simple, but profound reason: It wants to thank its huge customer base for the support they have been extending to this company over the many years for which it has been in business. During the course of the 10 years for which GlobalCompliancePanel has been in business, it has trained thousands of regulatory compliance professionals from around the world.

These professionals, belonging to such varied geographies as the US and Japan and India and Canada, have been able to meet their regulatory compliance challenges on account of these trainings. These trainings are relevant, focused and valuable, and are from some of the best known regulatory compliance Experts found anywhere on this planet.

It is these trainings that have been hoping these professionals in the regulatory compliance arena gain more insights into regulations from the FDA, the EMA and other such bodies around the world. These trainings have been consistently helping them to meet these challenges, as they give them a better and sharper understanding of the implementing these requirements.

These regulatory requirements can pose hurdles to the most experienced and brightest of regulatory compliance professionals in the medical devices, pharmaceutical, life sciences and food and biologicals areas, but not to those who undertake professional trainings from GlobalCompliancePanel. GlobalCompliancePanel’s panel of experts is here to help them overcome these challenges and hurdles.

This trend has been being witnessed from the time GlobalCompliancePanel entered the line of professional trainings. Any wonder then, that no fewer than 50,000 professionals have benefited from these trainings? What could be a better way of thanking such a huge base of customers than with this offer? GlobalCompliancePanel believes that a celebration should also be useful, and this is that this offer is!

Hurry up and enroll today. Happy learning!