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David Hanlon – What is Quality Assurance and Regulatory Affairs in Pharmaceuticals?

02 Nov

David Hanlon has built a career in Quality Assurance and Regulatory Affairs in pharmaceutical manufacturing. He specifically works in medical devices and diagnostics. This is one of the most important jobs for a pharmaceutical manufacturing company because it ensures that each manufactured product is pure and safe. There are a myriad of control measures and health regulations, which each product needs to meet. The Senior Vice President of Quality and Regulatory Affairs makes sure that each manufacturing site complies with all safety measures and that each product is properly identified and safe.

Maintaining the quality and the regulatory affairs of a product is an endeavor with many facets. It is essential for the person in charge to create a well-planned strategic roadmap for quality and regulatory organization structure. Pharmaceutical companies often have multiple manufacturing sites and multiple projects. Therefore the man or woman in charge of overseeing quality assurance and regulatory affairs must be organized, and able to keep track of each individual site. The best way to do this, is to create an overall strategic road map and apply the same strategies to each site.

Each site must also be compliant with the U.S Food and Drug Administration (FDA). The person in charge needs to be well versed in all of the health and safety regulations, so that they can ensure that each site is following the proper procedures and regulations. This department of the pharmaceutical company ensures that their manufacturing sites are following national and international regulations, and are producing high quality products. David Hanlon is highly skilled at maintaining his manufacturing sites and always makes sure they are following all of the necessary regulations.

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Posted by on November 2, 2015 in Society

 

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