How practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2019.
The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information regarding the do's and don'ts with HIPAA - I want to add clarity for compliance officers and what you guys…
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Added by Roger Steven on December 3, 2018 at 7:36am —
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The Food and Drug Administration (FDA) is the US’ regulatory agency for a variety of products that concern the health of their consumers. The FDA regulates everything concerning food, medicine, medical devices, veterinary products and cosmetics, as well as products that emit radiation. In addition to directly regulating all these through its set of regulations, the FDA also encourages innovation in the products and processes of products in these…
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Added by Adam Fleming on November 2, 2018 at 6:30am —
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What makes FDA guidelines so addictive that you never want to miss them? Well, FDA guidelines are something like the reminders for your car servicing. What happens when you buy a car? You get reminders from your dealer asking you to service it on time. The reason: your car is meant to be in fine shape when you…
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Added by Adam Fleming on August 23, 2018 at 5:56am —
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Added by John Robinson on February 16, 2018 at 5:29am —
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Added by John Robinson on February 2, 2018 at 5:22am —
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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 —
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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 —
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Added by John Robinson on January 9, 2018 at 4:56am —
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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 —
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Added by John Robinson on December 14, 2017 at 4:30am —
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Added by John Robinson on December 13, 2017 at 4:45am —
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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…
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Added by John Robinson on December 11, 2017 at 5:41am —
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Added by John Robinson on December 6, 2017 at 5:53am —
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Added by John Robinson on December 5, 2017 at 6:08am —
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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 —
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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 —
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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 —
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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 —
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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 —
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Manufacturing is a behemoth of an activity that straddles several industries. Modern manufacturing has come a long way from the days of its infancy, which can be traced to the Industrial Revolution of some 250 years ago. Getting advanced and refined at many stages; production or industrialization or manufacturing is the lifeblood of most of the world’s economies. Automation in the processes may have been introduced in many industries; yet, manufacturing…
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Added by Adam Fleming on October 24, 2017 at 6:20am —
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