Diffusion of the Quality Systems Innovation - Kirlew, Topaz Joy

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Résumé :
Over the past few decades, the FDA has mandated the need for quality systems (QS) for manufacturers of medical device, pharmaceutical and tissue/cell- based products to establish consistency with QS requirements worldwide and assure safe and effective medical products. The diffusion of this new innovation, the application of QS to this industry by Florida firms, is studied. This book assesses whether companies'' perceptions of QS as an innovation influence their likelihood of adopting this innovation into their business practices. Adherence to the QS regulation makes good business sense, serves to protect the public health and is a requirement, however, it is evident that not only are there US firms operating in this industry that do not have QS in place, but top management of these firms are not even cognizant of this requirement. This analysis will be helpful for all owners, top management and employees of firms operating in the health sciences industry to enhance awareness of the QS requirements and illustrate the need for developing a quality system to reduce liability for the manufacture of medical products regulated by the FDA....

Biographie:
Dr. Kirlew has a Doctorate in Business Administration, MBA, and BS in Medical Technology. With over 20 years of scientific, professional and management experience in the medical device, tissue/cell therapy & clinical trial arenas, she is currently Executive Vice President, Technical/Regulatory Affairs at a biotechnology firm in Florida....