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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…

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Added by John Robinson on August 11, 2017 at 8:12am — No Comments

Advocate General Opinion on Software Medical Devices

On 28 June 2017, Advocate General Sanchez-Bordona (AG) presented his …

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Added by John Robinson on August 10, 2017 at 8:38am — No Comments

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…

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Added by John Robinson on August 9, 2017 at 5:58am — No Comments

Health Buzz: The 10 Best States for Health Care

 

Health Buzz The 10 Best States for Health Care If 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…

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Added by John Robinson on August 8, 2017 at 5:47am — No Comments

It is important and necessary to document Software for FDA Submissions

It is important and necessary to document Software for FDA Submissions2 Software 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…

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Added by John Robinson on August 7, 2017 at 6:16am — No Comments

New HIPAA rules: Make sure you are in compliance because your liability has increased

Healthcare providers have until September 23 to put into place internal policies and procedures needed to comply with sweeping changes coming to the Health Insurance Portability and Accountability Act (HIPAA).

In January, the U.S. Department of Health and Human Services (HHS) released a set of rules, known collectively as the omnibus rule, designed to supplement and modify the privacy, security, breach notification, and enforcement…

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Added by John Robinson on August 4, 2017 at 5:53am — No Comments

Understanding 21 CFR Part 11 compliance for software validation and SaaS/Cloud

Understanding 21 CFR Part 11 compliance for software validation and SaaSCloud4

Software as a Service, SaaS is a method of delivering applications over the Internet. This small definition just about summarizes the core of SaaS: It provides Software as a Service using just the Internet. SaaS applications go by different nomenclatures such as on-demand software, hosted software, or web-based software.

SaaS is a fundamentally different method of delivering applications, because when a client chooses SaaS;…

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Added by John Robinson on August 2, 2017 at 6:48am — No Comments

Data visualization can have a great effect on statistical presentations

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It is said that a picture is worth a thousand words. This adage may appear figurative and allegorical when applied to the realm of statistics, but there is no denying the fact that a visual approach to statistics enlivens the subject like no other. A dash of pictorial work and some coloring at the right places enhance the…

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Added by John Robinson on August 1, 2017 at 6:03am — No Comments

Effective legal writing skills are essential for FDA submissions

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A number of reasons make cultivation of the art of effective legal writing skills for FDA submissions important. Documents that are submitted to the FDA…

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Added by John Robinson on July 31, 2017 at 6:27am — No Comments

Quality Assurance Auditing for FDA-regulated industries

Quality Assurance Auditing for FDA-regulated industries5

An effective audit constitutes the heart of an effective Quality System. The FDA and other regulatory agencies have emphasized this principle time and again. The purpose of an audit program is to ensure proper and thorough compliance with the guidelines set out by the regulatory agencies. A…

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Added by John Robinson on July 26, 2017 at 5:51am — No Comments

Which universities are pushing the boundaries in life sciences?

If you had to name the branch of university research that has the most tangible impact on mankind’s day-to-day activities, it is likely that the life sciences would be near the top of the list: not many days go by without the announcement of a new drug or gene discovery that has the potential to change lives or tackle disease.

Much of the best research in these fields takes place in the ultra-elite universities that excel in subjects across the…

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Added by John Robinson on July 25, 2017 at 6:14am — No Comments

Implementing ICH guidelines-compliant validation

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Professionals in the field of statistical analysis need to possess clarity on understanding and interpreting statistical concepts used to investigate quantitative ICH Guidelines, such as:

  • Analytical methods validation
  • Procedures and acceptance criteria in calibration limits…
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Added by John Robinson on July 24, 2017 at 6:06am — No Comments

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…

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Added by John Robinson on July 21, 2017 at 5:54am — 1 Comment

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 professio…

Development of technical training in the life sciences3

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…

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Added by John Robinson on July 19, 2017 at 6:21am — No Comments

The ways of applying ISO 14971, IEC 62304 and IEC62366-1 to medical device software

The ways of applying ISO 14971, IEC 62304 and IEC62366-1 to medical device software 3

Diligence, complete and proper examination and assessment of the gaps, and correction of the gaps right from the very start of product development are the core characteristics that need to go into implementing risk management of software used in medical devices.

These are the reasons for it:

  1. Lack of proper and complete implementation and gaps in them lead to major drawbacks such as production delays or…
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Added by John Robinson on July 13, 2017 at 6:47am — No Comments

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,…

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Added by John Robinson on July 12, 2017 at 6:20am — No Comments

Knowing what to expect in a HIPAA audit is the key to passing it

Knowing what to expect in a HIPAA audit is the key to passing it Healthcare professionals have to mandatorily carry out HIPAA audits in a way that satisfies the regulatory authorities. This needs a thorough understanding of the exact meaning and import of words contained in HIPAA. They also need to get a grasp of the purpose and intent conveyed in HIPAA’s language. This is absolutely essential for both the…

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Added by John Robinson on July 7, 2017 at 6:10am — No Comments

Safety Management and OSHA Compliance

Safety Management and OSHA Compliance 1

Why is Occupational Safety and Health Administration (OSHA) compliance necessary? For a simple reason: OSHA compliance is the surest legal way of ensuring safety at the workplace. Safety management and OSHA compliance go hand in hand and are deeply connected to and intertwined with each…

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Added by John Robinson on June 28, 2017 at 6:17am — No Comments

Documenting Software for FDA Submissions

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The Agile methodology is an important tool for software project management. It emerged out of the gradual efforts at arriving at a team based methodology of iterative software development. Its close association with software makes it as suitable to this field as Lean is to manufacturing.…

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Added by John Robinson on June 27, 2017 at 6:14am — No Comments

All about biosimilars –from development to registration

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Biosimilars can be described as near-copies of an original pharmaceutical product that another company may have manufactured. These products are versions of an original or innovative product, but are officially approved.

There is a misconception that they are similar to or are the same as generics, but this is not so in…

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Added by John Robinson on June 27, 2017 at 6:01am — No Comments

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The General Data Protection Regulation (GDPR), which has been codified as Regulation (EU) 2016/679, is a very powerful law regarding the protection of data of the half billion people who live in the European Union (EU). Having come into effect as a result of the European Commission having adapted the proposal for its creation on January 25, 2012; it will replace Directive…See More
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Laboratory Compliance webinar for $10 each at Online

August 16, 2017 at 10am to December 31, 2017 at 11am
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.Regulatory compliance learning, that vital ingredient needed for professionals in any area of regulatory compliance, is a put off, because many…See More
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How PMP Certification impact Your Salary?

Before investing money and time in PMP certification, it is very important for anyone to understand how the certification will impact salary. In this article, we will discuss PMP certification and its effects on salary, which can help you to decide whether you should go for it or not. We will focus on different perspectives of PMP salary, which is based on experience, the size of the company, designation and many others. Overview of PMP CertificationThough the PMP certification salary hike is…See More
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Safety - A Prerequisite 11 Replies

Whether working at home or outside, to observe safety should be our pre-requisite. The employer before anything must be sure of the safety of its employees especially the ones working in mines or any…Continue

Tags: products, safety

Started by Enna Henry. Last reply by Tara safe 9 hours ago.

Lean Six Sigma Black Belt Training in New York City

Welcome to MSys Training! We thank you for visiting MSys LSSBB training page. Attend our 4 days Lean Six Sigma Black Belt (LSSBB) training program with 100% pass rate, high quality course material,…Continue

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ITIL Certification Training - MSysTraining

The ITIL® Foundation is an entry level qualification in Information Technology industry. It gives participants information about the key elements, terminologies and concepts used in the ITIL Service…Continue

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Snowflake and Star Schema in Qlikview

In big name schema all of the facts are stored in one important table and the usage of number one key and overseas key courting different measurement tables are related with the fact desk.SNOWFLAKE…Continue

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What is Class Structure in Pega?

Class contains the rule by way of which objects behave. outline rules such as houses, sports, flows, html paperwork, etc. to be had to different subordinate classes. lessons are organized into a…Continue

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