Abstract
Much has been said and published recently on the subject of mergers and takeovers in the industry. For people working in a company affected by such developments, this is one of the most demanding challenges to be faced in the course of a career. This paper focuses on the merger of Ciba and Sandoz, which created Novartis and highlights the challenges confronting a GLP quality assurance (QA) organization in the pharma business. However, most of the topics addressed can be translated to other areas and are also applicable to takeovers. The history of the merger is illustrated, and the different phases of the merger process are explained. The new QA organization within Novartis Pharma Preclinical Development is presented, together with merger-related activities, such as the establishment of new contacts with customers and authorities, the creation of new QA SOPs, and GLP training procedures. Tips are also offered on how these challenges for a QA manager can be tackled. Copyright © 1998 John Wiley & Sons, Ltd.
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