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Course offering number:0810-205
Course ID:
1116
Biopharmaceutical Process Systems
6-8 October 2008
Amsterdam
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.