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John Robinson's Blog (212)

FDA Requirements for ensuring Premarketing Clinical Trial Safety



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Added by John Robinson on December 12, 2017 at 5:07am — No Comments

The FDA's requirements for non-IND Foreign Clinical Studies

The FDA grants marketing approval for certain types of medical products whose application is the result of foreign clinical studies, provided the products and the clinical studies meet certain conditions. The types of medical products…

The FDA's requirements for non-IND Foreign Clinical Studies 2

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Added by John Robinson on December 11, 2017 at 5:41am — No Comments

The Investigational New Drug Applications mechanism in the USA



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Added by John Robinson on December 8, 2017 at 5:40am — No Comments

The increasing role of the social media in healthcare



 

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Added by John Robinson on December 7, 2017 at 6:44am — No Comments

Technical Writing for the Pharma, Device and Biotech Industries



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Added by John Robinson on December 6, 2017 at 5:54am — No Comments

Quality Risk Management in the FDA-Regulated Industry



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Added by John Robinson on December 5, 2017 at 6:07am — No Comments

Export, Import and Trade Compliance Principle – an understanding

Export, import and trade compliance principle is a very important guiding standard for governing trade policies and ensuring compliance with the set national, regional and global trade norms. It helps to define an organization’s adherence to the export, import and trade compliance principle laid out by the government and also offers an…

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Added by John Robinson on December 4, 2017 at 4:49am — No Comments

Data Mining and Signal Detection in Pharmacovigilance

Data Mining and Signal Detection in Pharmacovigilance

A signal is described by the World Health Organization as any information that is reported on a possible or potential causal relationship between a drug and the adverse event it spawns. This relationship can be of virtually any nature, so long as it concerns the drug and the…

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Added by John Robinson on December 1, 2017 at 4:35am — No Comments

What are the components of a Financial Audit Program?

What are the components of a Financial Audit Program5

There are various core components of a financial audit program. First, an understanding of a financial audit:

  • A financial audit is a regular exercise carried out by qualified professionals from within or outside, to check the financial health of an organization
  • It involves having to verify, examine and analyze the various data…
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Added by John Robinson on November 30, 2017 at 5:37am — No Comments

What is logistics and supply chain management?

What is logistics and supply chain management

Logistics and supply chain management (SCM) constitute a very important element of businesses. Getting the logistics and supply chain management aspects right is necessary for the smooth flow of products from their source to destination, during the course of which many activities need to be performed.

Logistics and supply chain management is emerging as a…

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Added by John Robinson on November 29, 2017 at 4:53am — No Comments

The FDA’s Adverse Event Reporting Requirements

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The adverse event reporting system is an important highlight of the FDA’s adverse event reporting requirements. This is the mechanism through which adverse event reporting requirements are listed out for the FDA to take further action.

The adverse event reporting system may be understood as being a database…

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Added by John Robinson on November 28, 2017 at 5:43am — No Comments

Internal Audit Checklist for HIPAA

The internal audit checklist for HIPAA is one of the primary elements of HIPAA implementation. The passage of the Health Insurance Portability and Accountability Act (HIPAA) by the U.S. Congress in 1996 was aimed at regulating the way and process by which healthcare institutions across the country reveal the medical information of their patients.

The Department of…

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Added by John Robinson on November 24, 2017 at 4:45am — No Comments

What are the potential areas of risk management?

What are the potential areas of risk management.jpg The most critical aspect of risk management is the identification of potential areas of risk management. This helps the organization to stay focused on the areas in which it could possibly face risks, rather than taking an aimless view and shooting about in the dark.

In a very broad sense, the potential areas of risk management include all areas of a business, because simply…

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Added by John Robinson on November 23, 2017 at 4:41am — No Comments

Biotech and Pharmaceutical Courses are a gateway to a challenging and flourishing career

Biotech and Pharmaceutical Courses are a gateway to a challenging and flourishing career With over four million employed directly or in allied sectors and catering to the world’s largest market and research area, biotech and pharma is a fast growing industry. Its courses are designed to prepare individuals for this giant industry.

Biotech and pharmaceutical courses are much sought after by aspiring…

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Added by John Robinson on November 22, 2017 at 5:09am — No Comments

Understanding the importance and benefits of auditing Quality Management Systems

Understanding the importance and benefits of auditing Quality Management Systems.jpg

Auditing Quality Management Systems is a core requirement for ensuring that Quality Management Systems – defined as “…a set of policies, processes and procedures required for planning and execution” in the core business area of an organization, meaning those that impact the ability of the organization to meet…

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Added by John Robinson on November 21, 2017 at 5:20am — No Comments

Good Manufacturing Practices are essential for ensuring quality

Good Manufacturing Practices (GMPs) constitute one of the core components that go into the manufacture and distribution of foods, drugs and other pharmaceutical products. Good Manufacturing Practices are prescribed by regulatory agencies from around the world, the FDA and the EMA being among them.

The guidelines set out by these regulatory…

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Added by John Robinson on November 20, 2017 at 5:22am — No Comments

Regulations in the US and EU Dealing with Combination Products

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Registering and maintaining combination products in the US and the EU is a bit tricky, because these are disparate markets that are governed by different sets of regulations which are independent of each other. So, any business that wants to market combination products into the US or the EU must be completely aware of the nature and…

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Added by John Robinson on November 17, 2017 at 5:22am — No Comments

Forward brings its personalized healthcare service to Los Angeles

Forward, the San Francisco-based startup that’s looking to refashion healthcare services in Apple’s image, is…

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Added by John Robinson on November 16, 2017 at 5:07am — No Comments

Innovation in education looks to cure doctor shortage

Business News | 20 hours ago | Erica Apodaca

Arizona has a serious doctor shortage. The state is a “Designated Health Professional Shortage Area” and according to the latest numbers from the Health Resources &…

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Added by John Robinson on November 15, 2017 at 5:20am — No Comments

Rural health care centers provide low-cost care

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Providing health care services in rural areas is vital to addressing health disparity needs in the United States, said Candice King, the ACORN clinic’s executive director.

To get dental services she can afford, 73-year-old Juanita Jenkins has one of her sons drive her 16 miles from her home in the Duval neighborhood in northeast Gainesville to the Alachua County Organization for Rural Needs…

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Added by John Robinson on November 15, 2017 at 5:17am — No Comments

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Form I-9 Compliance at 26468 E Walker Dr, Aurora, Colorado 80016-6104

January 25, 2018 from 1pm to 2pm
OVERVIEWDon't spend another day worrying that you and your organization might end up in legal trouble from immigration law violations. The crucial information provided in this one-hour webinar will give you the knowledge and know-how needed to ensure your documentation is filled out appropriately, your records are kept correctly and your organization is legally compliant.WHY SHOULD YOU ATTENDImmigration law is one of the most pertinent and publicized issues in the United States right now.…See More
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PEGA Axis error: Parser already accessed

We have a PEGA frontend, from in which we're keying in double byte characters like japanese and being send to allotted java webservice through axis. this is working best when we ship singlebyte…Continue

Tags: pega_training, pega_online, pega

Started by Soujanya Naganuri on Thursday.

VMware player error on install vmware tools.

 I've installed the last version of VMware player (4.0.2) and created a virtual machine with ubuntu 10.04. However, some operations with …Continue

Tags: training, online, vmware

Started by emmablisa Dec 1.

All About QlikView

QlikViewQlik relies on sophisticated analytics that enables data discovery using an in-memory engine to analyze data for patterns not visible via SQL data structures or queries. The company’s two…Continue

Tags: Safety, Qlikview

Started by nicolewells Nov 25.

Occupational Health and Safety 5 Replies

Health and safety are important aspects of an organisation’s smooth and effective functioning.  Did you know that workplace health & safety injuries cost Australian businesses over $60 billion…Continue

Tags: Safety, and, Health, Occupational

Started by WHS Solutions. Last reply by Tara safe Nov 16.

QlikView for its Safety Strategic Business Intelligence Solution Worldwide

QlikTech (NASDAQ:QLIK), a leading…Continue

Tags: Qlikview, safety

Started by nicolewells Nov 15.

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