0 11 min 2 yrs

A professional trainings provider in the areas of regulatory compliance, human resources, healthcare and IT, offers trainings for professionals in the field of pharmaceuticals and medical devices on ways of managing risks in their professions.

Risk is at the heart of any activity. Almost any activity carries some or another element of risk. Risk is comparable to the side effect of a drug. While the drug performs its function and meets its purpose; it also carries with it the side effects that are inevitable and unavoidable to anyone consuming the drug. Similarly, a risk is a necessary partner of an activity or action. There is almost no action that does not come with some element or level of risk. In business, risk is directly proportionate to the reward. It is generally considered that the greater the risk; the greater the reward.

Risk assessment is absolutely essential for medical devices and pharmaceuticals
“No action comes without a risk. So, it is necessary for organizations in the medical device and pharmaceutical industries to take stock of the elements of risk in their business. Making risk assessments in order to mitigate the severity of the risk is very important, although these risk assessments can be subjective and based on the individual’s ability to perceive and interpret risk.
Making a perceptive and proper risk assessment is the first step to understanding ways of meeting regulatory compliance, because risk assessment is a regulatory compliance requirement. The aim of the professional trainings is to provide insights to professionals in the regulated industries on ways of getting their risk assessments right”, said Satish Naraharimurthy, Founder and CEO – Aug 3, 2016.

Risk assessment straddles qualification, verification and validation
Shahanshah Manzoor, Co-Founder and Chief Marketing Officer believes that professional trainings are necessary for professionals in the medical device and pharmaceutical fields not only because risk assessment is a regulatory requirement, but also because getting the risk assessment right is the basis to a sound product development process. This is a means to understanding how to put in place a process that includes qualification, verification and validation. It is thus very important for organizations in the medical devices and pharmaceutical fields to have proper trainings on how to assess risk. Trainings are built to provide just this, he says, adding that these experts have helped many organizations in these industries carry out their risk assessments and get their regulatory process right.

Risk assessment trainings that are comprehensive
“Professional trainings are aimed at imbibing all the aspects of risk assessment for pharmaceutical and medical device professionals. Our trainings are very comprehensive. They carry the experience that our experts have gained over many years of working in the industry. Impart trainings on all the possible aspects of risk assessment, such as the regulatory derivations of Risk Assessment, risk expectations, ways of properly analyzing and determining risk, the fundamental equations necessary for risk assessment, the various tools that exist for Risk Assessment and their definitions, and ways of assigning and defending proper risk”, said Liju Mathew, Co-Founder and Chief Business Development Officer.

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