The Purpose of Risk and Quality Management: The Case of Janssen Pharmaceuticals

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Purpose of risk and quality management It is no secret that risk is prevalent in the healthcare industry. Healthcare organizations carry a large amount of risk just in their daily operations. Healthcare organizations not only have to worry about risks to their patients, but their staff, financial stability, or even a natural disaster. A healthc organization must have a risk management department with trained and qualified individuals that know how to handle various issues within the organization. At Janssen, they have a lot of risk when it comes to their product. They have compliance laws that must be meticulously followed to prevent severe punishments such as multi-million dollar lawsuits or imprisonment from criminal convictions. They must promote their products lawfully and keep them regulated by the FDA and keep medical decision making free from improper industry influence. To go along side with risk management, quality management also plays a vital role within a healthcare organization. Quality management oversees the quality of the services the organization provides as well as the products it may sell. With pharmaceuticals, the quality must be consistent and how Janssen maintains this quality must be overseen. Quality control is an important factor for them. Controlling all of the various elements within their production and also the satisfaction of their consumers plays a vital role for continual success. Key Concepts At Janssen Pharmaceuticals, managing the bountiful risks is mandatory because producing and developing medicine has the potential risk of adverse reactions along with many others risks, and even the possibility of a fatality. Understanding that medical science is rapidly evolving and they want to k... ... middle of paper ... ...ing development and manufacturing (Quality Risk Management, 2006). The population is every bit of reliant on medication to manage several life threatening conditions, and risk comes along with the medication and should not be overlooked. There are several laws and regulations that are set into place for specific reasons such as FDA Amendments Act, which sets forth risk identification, evaluation and mitigation objectives regarding post market drugs. This helps the overall population by making pharmaceutical companies more adherent to drug safety and incorporating safety into their pre-market processes and also once the drug has been released to the public. Janssen Pharmaceuticals have had a great run with their company with only a few hiccups along the way. They have learned through experience that putting profit before people can and does have consequences.

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