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John Robinson's Blog (225)

The Foreign Corrupt Practices Act – a look



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Added by John Robinson on January 18, 2018 at 5:04am — No Comments

The FDA Export Reform and Enhancement Act of 1996 – a brief understanding



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Added by John Robinson on January 17, 2018 at 4:38am — No Comments

Effective Complaint Handling Guidelines serve as a basis for improvements in medical devices



Effective Complaint Handling Guidelines serve as a basis for improvements in medical devices1 https://globalcompliancepaneltraining.files.wordpress.com/2018/01/effective-complaint-handling-guidelines-serve-as-a-basis-for-improvements-in-medical-devices1.jpg?w=150 150w" sizes="(max-width: 266px) 100vw, 266px" />Far from being frowned upon, complaints should serve as…

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Added by John Robinson on January 16, 2018 at 4:44am — No Comments

Business Process Management in Healthcare helps reduce inefficiencies



What are the components of a Financial Audit Program1 https://globalcompliancepaneltraining.files.wordpress.com/2017/11/what-are-the-components-of-a-financial-audit-program1.jpg?w=150 150w" sizes="(max-width: 300px) 100vw, 300px" />

For many years before the advent of automation and computerization ,…

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Added by John Robinson on January 12, 2018 at 4:44am — No Comments

Digital Marketing for Pharmaceutical companies offers tremendous opportunities

There is enormous potential for digital marketing for pharmaceutical companies. Proper exploitation of the social media can take pharmaceutical companies to their market in a more pinpointed and accurate manner than traditional marketing.

Gone are the initial days of reluctance on the part of pharmaceutical companies to…

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Added by John Robinson on January 11, 2018 at 4:33am — No Comments

Unravelling the DHF, Technical File and Design Dossier

Design History File (DHF), Technical File and Design Dossier are important regulatory documents for a medical device. Design Control and Design History File are regulatory documents for medical devices in the FDA, while the Technical File and Design Dossier serve the same purpose for the EU's regulatory body, the MDD.

The Design History…

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Added by John Robinson on January 10, 2018 at 4:53am — No Comments

Design Control for Medical Devices



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Added by John Robinson on January 9, 2018 at 4:56am — No Comments

Aspects of Regulatory History in the US

The beginnings of all that the USFDA regulates can be traced right to the early decades of the founding of the nation. In a sense, the FDA, even if came to be called by that formal name much later; embodies the discipline and value set that the new created nation sought to represent. Regulation of all aspects of American life was deeply ingrained…

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Added by John Robinson on January 8, 2018 at 5:22am — No Comments

Good Documentation Practice Guideline is simple: just write

Good Documentation Practices are the soul of many regulated industries. The FDA, like all other regulatory agencies, makes GDP a central element of its regulations, and bases it on the principle of evidence. For the FDA and other regulatory agencies across the world, what is not documented is nonexistent.

Good Documentation…

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Added by John Robinson on January 5, 2018 at 5:06am — No Comments

What is risk-based monitoring?

Sponsors of clinical studies adapt many methods that are aimed at reducing the complexity of clinical trials. They also look for methods by which they can increase the efficacy of the results, while keeping the costs low. Risk-based monitoring is one of these methods.

How is risk-based monitoring understood?One can understand risk-based monitoring in several ways. This varied understanding is because there is no one definition or…

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Added by John Robinson on January 4, 2018 at 5:04am — No Comments

FDA Warning Letters – an understanding

As the primary regulator of the biological, healthcare, life sciences and other related industries; the FDA has power and authority over how its work is carried out. FDA Warning Letters are among the primary mediums through which it enforces its authority.

The FDA issues a Warning Letter to a company when it determines, following…

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Added by John Robinson on January 3, 2018 at 4:51am — No Comments

Tougher FDA import rules are aimed at putting strict controls on imports

Tougher FDA import rules are aimed at putting strict controls on imports 3 https://globalcompliancepaneltraining.files.wordpress.com/2017/12/tougher-fda-import-rules-are-aimed-at-putting-strict-controls-on-imports-3.jpg?w=1400 1400w,…

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Added by John Robinson on December 14, 2017 at 4:29am — No Comments

Best Practices in Vendor Risk and Compliance Management



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Added by John Robinson on December 13, 2017 at 4:44am — No Comments

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

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What's your favorite motivational/safety quote? 103 Replies

Favorite Motivational Quote: If you want something, you'll find a way - If not, you'll find an excuse.Favorite Safety Quote: Don't learn safety by accident!Continue

Started by Michelle Sears. Last reply by Lissa Jan 11.

Python Online Training by QA Training Hub

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Forklift Training in Calgary

Do you wish to learn forklift driving? A forklift is a type of industrial vehicle that firstly lift the material and then transport it. The forklift machine is capable of lifting heavy loads by…Continue

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