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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 4:30am — No Comments

Best Practices in Vendor Risk and Compliance Management



Best Practices in Vendor Risk and Compliance Management.jpg https://globalcompliancepaneltraining.files.wordpress.com/2017/12/best-practices-in-vendor-risk-and-compliance-management.jpg?w=838 838w,…

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Added by John Robinson on December 13, 2017 at 4:45am — No Comments

FDA Requirements for ensuring Premarketing Clinical Trial Safety



FDA Requirements for ensuring Premarketing Clinical Trial Safety 2 https://globalcompliancepaneltraining.files.wordpress.com/2017/12/fda-requirements-for-ensuring-premarketing-clinical-trial-safety-2.jpeg?w=844&h=562 844w,…

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Added by John Robinson on December 12, 2017 at 5:08am — 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



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 6:45am — 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 5:53am — 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 6:08am — 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 4:50am — 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 Compliance4all on December 1, 2017 at 5:11am — 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 Compliance4all on November 28, 2017 at 5:30am — 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

Differences between Device and Drug Clinical Research

Medical devices and drugs clinical research have their differences in approach and methodology. It is necessary to have a clear understanding of these differences if one embarks upon a study involving either or both of these.

Some of the major differences between device and drug clinical research include:

Requirement for a study:

One of the important differences between device and…

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Added by Roger Steven on November 23, 2017 at 6:16am — No Comments

Philippine anti-drug agency chief vows 'rule of law'

The new chief of the Philippines’ anti-drug agency has promised a fresh approach to the controversial war on drugs, “based on the rule of law”.

Aaron Aquino said that since he took over in August, only one suspect had been killed in 1,341 operations.

Thousands have died in the anti-drug campaign since it was launched by President Rodrigo Duterte in 2016.

Rights groups say Mr Duterte has sanctioned extrajudicial killings by vigilantes…

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Added by Compliance4all on November 23, 2017 at 4:55am — 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

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