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August 2017 Blog Posts (20)

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…

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Added by John Robinson on August 18, 2017 at 7:08am — No Comments

The GDPR differs Significantly from EC Data Protection Directive 95/ 46

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…

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Added by Compliance4all on August 16, 2017 at 5:32am — No Comments

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 do campuses respond to students with mental issues?

Perhaps no educational campus is free of students with some or another kind of mental or emotional issues. Considering the wide diversity of students that enroll into American colleges and the varied backgrounds they come from; it is no surprise that American colleges will have to deal with such students.

There is a need for institutions that come across students with emotional or mental issues to learn to deal with the issue. While on the one hand, administrators of educational…

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Added by Roger Steven on August 9, 2017 at 7:41am — 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 5:59am — No Comments

Relationship Between an EM Excursion Program and CAPA

The FDA’s regulations on cleanroom environmental monitoring (EM) are based on the assumption that any person who enters a cleanroom is likely and almost certain to have brought contaminants in one or another form with him. The FDA’s regulations on cleanroom environmental monitoring are built on the thinking that microorganisms can assail even the cleanest of systems, which is why its regulations on cleanroom…

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Added by Compliance4all on August 9, 2017 at 5:39am — No Comments

Does fixing a retirement age for physicians help improve the healthcare system?

The medical profession is different from most others in one vital aspect: Practitioners of this profession don’t retire. The profession allows the physician to continue for as long as her physical and mental faculties allow her to. The US’ Supreme Court judges too, don’t retire, but theirs is judicial…

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Added by Roger Steven on August 8, 2017 at 7:00am — 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 5:48am — No Comments

Actions for Noncompliance of cGMPs in the Quality Control Laboratory

Quality controls in laboratories are a major area for which the FDA issues 483’s. A laboratory is the venue for many activities, all of them of varying importance to the product. When controls in laboratories are not up to the standard, such a laboratory could produce products that do not meet quality and processes expectations, and hence invite 483’s.

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Issues with drug quality, drug integrity and data integrity, as well as data fabrication and human errors…

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Added by Compliance4all on August 8, 2017 at 5:36am — 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 team…

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Added by John Robinson on August 7, 2017 at 6:17am — No Comments

Latest Trends in Human Error Issues in the Industry

To say that the manufacturing industry is huge is to make a huge understatement. It is an activity that spans entire industries and is the lifeblood of many economies, right from advanced to developing ones. Despite the advancement in automation in the processes of many industries, manufacturing is still heavily dependent on human labor.

This makes manufacturing an activity that is prone to human error, because wherever there is human involvement, there is scope for human error. Why…

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Added by Compliance4all on August 7, 2017 at 5:40am — 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

The role of validation in HACCP

The Hazard Analysis and Critical Control Point (HACCP) is a process control system that is aimed at identifying the points or areas at which hazards (dangers) may arise in the food chain. It prescribes strict measures for manufacturers and transporters of food products to prevent contamination and the resultant hazards. Control of hazards in the food chain has always been a need, but HACCP assumes added significance in today’s…

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Added by Compliance4all on August 4, 2017 at 5:31am — No Comments

7 Keys to Compliance Excellence that Form the Foundation for Any Excellent Organization

In any industry, compliance is everything; be it highly specialized fields such as the life sciences, healthcare, medical devices or non-technological areas such as food and clothing. Why do companies need to be compliant? It is simply because being in compliance with the required regulatory requirements helps the organization to achieve the most positive outcomes needed for a business:

  • It earns them a good reputation
  • Increases stakeholder and customer…
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Added by Compliance4all on August 3, 2017 at 5:48am — No Comments

Learning how to manage the HIPAA Business Associate process is important

Most healthcare providers or organizations that are described as Covered Entities by HIPAA, engage vendors as HIPAA Business Associates for carrying out many of their services on their behalf. HIPAA defines a Business Associate as a person or an entity who carries out some or all functions or activities that involve the use or disclosure of Protected Health Information on behalf of, or of providing services to a…

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Added by Roger Steven on August 2, 2017 at 8:13am — 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 6:50am — No Comments

MS Excel can be a wonderful tool for carrying out umpteen functions

Mastering MS Excel formulas and functions can make a miracle out of this program. When used optimally, MS Excel can be a wonderful tool for carrying out umpteen functions and optimizing work related to a number of departments. For example, the Accounts Department can do a number of important functions such as loan repayment calculation, generating a profit and loss statement, solve complex mathematical and engineering problems, and carry out anything that involves addition, subtraction,…

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Added by Compliance4all on August 2, 2017 at 5:35am — No Comments

Data visualization can have a great effect on statistical presentations

Data visualization 2

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

Understanding HACCP and risk based HACCP

Hazard Analysis and Critical Control Point (HACCP) is an important system aimed at bringing down the risk of safety hazards found in food consumed all over the world. It is an internationally recognized system. When it was enacted in January 2011 as part of the FDA’s Food Safety Modernization Act; it was considered a very sweeping piece of legislation for the food industry.

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Identification and control of…

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Added by Compliance4all on August 1, 2017 at 5:39am — No Comments

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