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Overview This course is designed for people who are growing in their knowledge of sterile product production. It will be a "how to" course where the instructor will explain the reasoning as well as the procedures that should be used to process sterile products. The instructor will present different areas of study and present them with a practical approach so that the participant can see how the subject matter applies to the participant's work either now or in the future. In addition to discussing the particular subjects the instructor will explain how pharmaceutical regulatory requirements are met through the use of aseptic techniques. The instructor has decades of experience in working with and within the regulated pharmaceutical industry in the U.S. He will be covering topics that he is familiar with and will present them in a manner aimed at workers who may have not been trained in sterile product production, but now wish to expand their level of understanding. ...

Overview Vendor Oversight is currently a hot topic as Sponsors and vendors aim to get to grips with what is really required.  You don’t want to outsource and then expend multiple resources to manage and oversee your trial.  As a vendor you want to get on with the outsourced clinical trial in the most effective way feasible without micromanagement from your sponsor company.   What is required to compliantly and efficiently implement vendor oversight? What are the risks and challenges of not getting this right from the beginning? This course will aim to work through some of these challenging topics with time given to work through specific scenarios from the attendees.   Areas Covered in the Session Meeting Regulatory Expectations: recent industry and regulatory items that impact Vendor Oversight to include ICH E 6 R2 Outsourcing models: what could work best for your organization Selecting the right providers for your outsourcing model What are the ...

Overview The new Microsoft tools provides the possibility of using large amount of data, but even more important, combine different data source into one dashboard. The ease of creating and maintaining these dashboards is awesome. By taking data-drive decisions as a spearhead, the business get opportunities to use data on scale what was never possible before. This seminar will update you with the strategic side of moving towards this third revolution: the change towards data-driven decision based businesses. Using data-driven decision based business and -with it- data analytics will change the way you’re doing business. And thereby it changes organizations itself. If you want to know how to prepare yourself towards this revolution, you find the answers in this seminar. I discuss business cases of successful adoptions of Power BI and the way organizations adopt the tooling. After this session you are able to create your own strategy to implement Power BI in your organization....