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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



The Investigational New Drug Applications mechanism in the USA.jpg https://globalcompliancepaneltraining.files.wordpress.com/2017/12/the-investigational-new-drug-applications-mechanism-in-the-usa.jpg?w=866&h=650 866w,…

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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



 

The increasing role of the social media in healthcare 6 https://globalcompliancepaneltraining.files.wordpress.com/2017/12/the-increasing-role-of-the-social-media-in-healthcare-6.jpg?w=862&h=574 862w,…

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

MSHA Dam Safety Program

The Mine Safety and Health Administration (MSHA), a division of the U.S. Dept. of Labor, provides a complete listing of hazard classifications for dams.

 

These include:

  • Low Hazard Potential
  • High Hazard Potential
  • Significant Hazard…
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Added by Jam Blanco on December 6, 2017 at 9:34am — No Comments

How to protect your new business from crime

Image by Codelocks Ltd (Creative Commons)

Starting a new business can be an exciting prospect. With the right idea, lots of hard work, and let’s face it, a bit of luck, you may find yourself at the helm of a very successful…

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Added by Alex on December 6, 2017 at 8:04am — No Comments

Technical Writing for the Pharma, Device and Biotech Industries



Technical Writing for the Pharma, Device and Biotech Industries 3 https://globalcompliancepaneltraining.files.wordpress.com/2017/12/technical-writing-for-the-pharma-device-and-biotech-industries-3.jpg?w=690&h=660 690w,…

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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



Quality Risk Management in the FDA-Regulated Industry.jpg https://globalcompliancepaneltraining.files.wordpress.com/2017/12/quality-risk-management-in-the-fda-regulated-industry.jpg?w=874&h=490 874w,…

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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

Top Dos and Don'ts for Software Testers

As we all know by the time a software development process approaches the final stage, it needs to go through numerous tests in order to make sure it is free of bugs, able to handle a load and ready for use.…

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Added by Shaurya Sinha on December 4, 2017 at 12:16am — No Comments

How to Fine-Tune Your Instagram Strategy for Superior Brand Awareness

Social media marketing is inescapable for big or small businesses today given the huge volumes of their audiences. Instagram, with its visual focus, has emerged as the darling of marketers for engaging the target audience that has already grown to a humongous 800 million active monthly users. However, you need…

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Added by Harris Scott on December 3, 2017 at 5:04am — No Comments

4 Easy Tools for Integrating Instagram Feed to Your Website

The popularity of Instagram as a social media site is rising with each passing day. In the fullness of time, many digital marketers have grabbed the opportunity and are now exploiting it as an ideal…

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Added by Harris Scott on December 3, 2017 at 3:42am — No Comments

5 Eye-Opening Instagram Facts That Social Media Expert’s Didn’t Tell You

Instagram has witnessed extreme growth over the past couple of years. As a result, a majority of the businesses have flocked into using the application which is powered by visuals. But, learning just the basics of Instagram is like scratching the surface and not going any further. You need to revamp your Instagram game to appeal…

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Added by Annora Florence on December 2, 2017 at 9:30am — No Comments

How the Future of Finance Gives You Total Control

In the world of commerce, internet is king as it never sleeps and continues to take transactions long after you and I have laid to rest for the night. With the evolution of finance and online transactions the internet world has taken large steps to make it easier for the consumer and investor to feel more safe and secure with the funds which are being processed.

Remember when Paypal came on the scene? “E-commerce”? It was still like a toddler –…

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Added by Adam Fleaming on December 1, 2017 at 5:10am — 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

The FDA's Adverse Event Reporting Requirements5.jpg

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

The vital area of Pharmaceutical Process Engineering

Pharmaceutical Process Engineering is an often-overlooked area in the field of pharmaceutical manufacturing. It calls for a high degree of precision and coordinates technical expertise and communication between professionals involved at diverse levels of the manufacturing unit, such as pharmaceutical researchers, chemical engineers and industrial. It is concerned with how pharmaceutical development is related to the application of major concepts and…

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Added by Adam Fleaming on November 28, 2017 at 5:27am — No Comments

Construction safety training

Construction Safety Job Options

Construction safety specialists naturally examine and investigate building locations to recognize probable physical, chemical and biological threats. They also discussion sufferers of workstation fates and dangers, produce reports and protective strategies for managers, maintain a record or logbook of civil site actions and recommend customers on proper workstation procedures.

Fresh construction safety officers may be appointed…

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Added by Nakul Pratap on November 27, 2017 at 2:40am — 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

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John Robinson posted a blog post

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 productshttps://globalcompliancepaneltraining.files.wordpress.com/2017/12/the-fdas-requirements-for-non-ind-foreign-clinical-studies-2.jpg?w=800&h=504…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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