Learn any professional courses for $10 only

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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.

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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

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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.

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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.

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Contact US:

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com

support@globalcompliancepanel.com

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

Website: http://www.globalcompliancepanel.com

Registration Link –

https://www.globalcompliancepanel.com/webinars_home?wordpress-seo-gcp-webinar-offer-2017

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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

 

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.

Development of technical training in the life sciences

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Training and Development is a highly developed and evolved, broad body of knowledge. Many employees place themselves at a disadvantage vis-à-vis their colleagues in the absence of the right professional training and development. If employees have to consistently close gaps in their learning, they need to keep upgrading their knowledge and skills. They should also use training and development to understand how to meet the regulatory requirements the organization is required to comply with.

Difficulties of training and development in the life sciences

Development of technical training in the life sciences

This said; the need for technical training in the area of life sciences has not got the attention that many other areas have. Technical training and development skills in the field of life sciences is extremely important in helping professionals in that important area get proper guidance of the regulations in the areas of life sciences and benefit from them.

Technical training in the life sciences applications, however, has its challenges.  Mention needs to be made of two of them: A) The field of life sciences consists of activities such as formulating Standard Operating Procedures (SOPs), work instructions, and having to carry out tests and clinical trials, all of which are pretty complex. B) Regulations are often considered complex to grasp and implement.

A full understanding technical training for the life sciences

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GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a two-day seminar, at which professionals in the life sciences will become more familiar with training and development. It will also ease the complexity of their training needs.

The Director of this seminar is Charles H. Paul, who is the President of C. H. Paul Consulting, Inc., a regulatory, manufacturing, training, and technical documentation consulting firm that is celebrating its twentieth year of existence in 2017. Want to understand the importance of technical trainings for the life sciences and know how to implement legally compliant life sciences training programs for your organization? Then, please register for this seminar by visiting Development of technical training in the life sciences.  This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Kindling the interest in training for the life sciences

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Charles will essentially seek to ignite the training and learning needs of talented and technically competent training professionals who may need more focused instruction and direction in the area of technical training in the Life Sciences. He will examine the guidance that all training professionals need at all skill levels to truly build and sustain a training organization in today’s difficult corporate environment, and show how to effectively identify gaps in workforce training and compliance documentation and build effective and inexpensive training materials with the tools that are available.

A very important takeaway of this seminar is the learning of how to integrate Training & Development with compliance, so that the participants can leverage the benefits of compliance to improve the performance of the workforce and the overall performance of technical operations.

Personnel in the life sciences industries that are associated with training, such as Directors of Training, Training Supervisors, Training Coordinators, Training Developers, Instructional Designers and Instructors will benefit from this seminar. The following is the agenda of this seminar:

  • Introduction to Training and Development in the Life Sciences and the Relationship between Training and Regulatory Compliance
  • Training and Development Basics
  • The Building Blocks of Human Performance
  • Building a Training and Development Organization – Leverage what you have and Negotiate for What You Don’t
  • Perform a Documentation and Training Analysis – Discover the Gaps
  • Training Materials – SOPs and Work Instructions as Training Materials – It’s not as easy as you think! Leverage the Opportunity!
  • Working with Subject Matter Experts and Outside Consultants
  • Case Study Review and Discussion – This Approach Works!

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

Design of Experiments (DoE) for Process Development and Validation

Design of Experiments (DoE) is a very important process development and validation component in several kinds of industries. DoE for process development and validation involves carrying out a number of tests recurrently and steadily over a period of time. Its responses are then observed.

DoE is important for process development and validation as it offers an understanding of the predictability and reproducibility of an experiment. Fundamentally, Design of Experiments for process development and validation seeks to rule out fluke or chance in the methods needed for bringing about control for a product.

DoE in medical devices

In the area of medical devices, guidelines for Design of Experiments for process development and validation are set out in the Global Harmonization Task Force (GHTF) Process Validation Guidance for Medical Device Manufacturers. This document offers guidance in the area of Design of Experiments for process development and validation by suggesting the exact areas in which design of experiments should be applied during Process Validation.

The GHTF guidance also suggests the use of both screening and response surface designs during Operational Qualification. It further requires Design of Experiments for process development and validation to be used during various phases of design controls. These include:

o  Design and development planning

o  Design verification

o  Design validation

o  Design transfer

o  Design changes.

Get a full understanding of Design of Experiments for process development and validation

The ways of approaching Design of Experiments for process development and validation will be topic of a two-day seminar that is being organized by GlobalCompliancePanel, a highly respected provider of professional trainings for the areas of regulatory compliance.

Jim Wisnowski, who is the cofounder of Adsurgo LLC and co-author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP, will be the Director at this seminar. In order to gain a full understanding of the principles and application of Design of Experiments for process development and validation; please register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900794?linkedin-SEO .

This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

All about Design of Experiments for process development and validation

This seminar will offer total and all-round understanding of all the aspects of Design of Experiments for process development and validation.

Process development studies need to be completed before a process control plan is developed as part of an overall risk management strategy. These process development studies help gain knowledge and understanding about the impact of variation in process parameters on the variation in the product quality characteristics of the product.

An explanation of the methods used

The methodology of Design of Experiments for process development and validation offers a means for identifying process parameters, which impact product quality (critical process parameters) and determine the functional relationship that links the process parameters to those critical quality attributes.

Design of Experiments for process development and validation uses screening designs such as 2k factorial and D-optimal designs to determine critical process parameters. Design of Experiments for process development and validation use response surface designs, such as Central Composite Designs (CCDs) and I-optimal designs for fashioning the functional relationship between those critical process parameters and the critical quality attributes.

A primer on statistical analysis

This seminar on Design of Experiments for process development and validation will present a primer on statistical analysis, during which it will focus on the methods required for analysis of designed experiments. Jim will then move on to the steps to a proper DoE, during the process of which he will demonstrate the nature and uses of important risk management tools such as Ishikawa and FMEA, which can be used pre and post DOE studies.

The Director will also teach how to generate and analyze multiple screening and response surface designs, and why and how each are used. After teaching participants how to present the results, Jim will explain how to update the risk management tools using the results of the studies.

This session on Design of Experiments for process development and validation will cover the following areas:

o  Identify critical quality attributes (CQAs) that will be used as responses in your designs

o  Utilize risk management tools to identify and prioritize potential critical process parameters

o  Identify critical process parameters and develop a functional relationship between those process parameters and your critical-to-quality attributes (CQAs) using both screening and response surface designs

o  Be able to design and analyze screening designs including a factorial, fractional factorial, and D-optimal design

o  Understand the need for adding center points to a design

o  Be able to design and analyze response surface designs including central composite designs (CCDs), Box-Behnken designs, and I-optimal designs

o  Present results of DOE studies

o  Use systematic understanding from DOE studies to update the control plan that is part of the overall risk management plan.

Ways of conducting a hassle-free internal and supplier audit for medical devices

Carrying out efficient and effective internal and supplier audits that meet all the requirements of external auditors is a must for medical device manufacturers. These audits should not only serve this purpose; they should also add value to the medical device organization.

Part of both ISO 13485 and QMS

Internal audits are required as part of ISO 13485 and the FDA’s Quality System Regulation (QMS). However, these procedures are quite complicated for many professionals in the medical device industry.  They are often confusing and cumbersome, mainly because of the jargon and regulatory language they contain. Many organizations find it difficult to get the import of these words while wading through them all the way to a successful internal audit.

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A tad complicated

Another couple of complicating factors come into play: Since the FDA does not look at the content of internal audits; many medical device organizations do not get feedback on the true effectiveness of their internal audit system from the FDA during the time of FDA inspections.

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Secondly, while on the other hand ISO 13485 auditors do look at internal audits; they are most concerned with the process. For them, a proper definition of a process that meets the requirements of the standard and the assurance that the company is following these are more important than anything else.

Auditor training is necessary

Both these regulations require that the medical device manufacturer define Auditor training. But there is a catch, because auditor training sometimes just requires reading the company’s procedure, while most external auditors will look for more than this.

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How does a medical device company extricate itself out of this quagmire? The solution to all these vexing questions will be offered at a two-day seminar from GlobalCompliancePanel, a globally known provider of regulatory compliance trainings.

At this seminar to enroll for which you need to just log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900601SEMINAR; the Director, Betty Lane, who is Founder and President, Be Quality Associates, LLC, will explain all the issues relating to these aspects of external and internal supplier audits, in a way that is comprehensible and easy to implement.

In the process of explaining what makes for efficient and effective internal and supplier quality systems auditing for medical devices; she will also offer an explanation of best practices for creating and managing a value-added auditing process that will meet both company business needs and regulatory requirements.

At this seminar, which has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion; Betty will get participants to review all the quality management system requirements of FDA and ISO 13485 and then allow them to learn how to set up and manage an audit system that complies with these requirements, yet is risk-based so that their organization makes the most efficient use of auditing resources for both internal and supplier audits.

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She will also include interactive exercises at this two-day session, which will help to strengthen the fundamentals of conducting and documenting quality system audits. The auditing principles taught in this seminar will be based on ISO 19011:2011 Guidelines for auditing management systems.