Send us your interest if this course is currently not offered or the current schedule does not accomodate your schedule. It is often necessary to understand interest a semester in advance for planning and scheduling. Companies and organizations can often request a course if the group is large enough. This doesn't mean that we can make accommodations in every case. However, we will utilize and maximize our available resources as best as we can. Thanks for letting us know your interests and we will respond as soon as we can.
This class covers fundamental principles of Computer Validation and cGMP requirements related to computer validation, phases/life cycle of computer validation and computer systems, and documentation requirements. You’ll get an overview of validation principles for both automation and information systems and review the major areas targeted by regulatory auditors (FDA and International) in inspections. Samples of assessment tools are provided
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