The Center for Professional Advancement, Amsterdam
12-14 November 2007
Who Should Attend:
This course is intended for operating and engineering personnel involved in specifying, designing, installing, commissioning and validating biopharmaceutical production equipment. The course will cover the entire project lifecycle, with particular focus on key decision points, design parameters and drivers for success.
Description:
All biopharmaceutical products are manufactured in a regulated environment to ensure the quality and safety of these substances. Biopharmaceutical facilities are licensed to manufacture a specific product and are inspected by regulatory agencies such as: FDA, European Agency for the Evaluation of Medicinal Products (EMEA), and Medicines Control Agency (MCA) in the UK. These agencies provide a framework for process equipment GMP requirements. Process equipment suppliers also offer specific design features to optimize operation, cleaning and maintenance of integral production modules. Design specifications for biological process equipment including process requirements and functional requirements to define material selection, instrumentation and controls, and for interfacing with facility utility systems will be discussed. Process and facility validation requirements for the process modules will be related to their ultimate use. Finally, the process unit modules must be able to operate and perform as an integrated production train. Practical solutions to real issues will be emphasized.
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