Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data.
Why Should You Attend:
You should attend this webinar training on computer system validation regulated by FDA, if you are responsible for planning, executing or managing the validation of a system. This is true whether using a "wet" or ink-based signature, or an electronic signature. It is also true whether maintaining paper-based or electronic records. Different requirements pertain to each type of signature or record, and there is a specific set of best practices that need to be followed for either type.
Areas Covered in this Webinar:
Who Will Benefit:
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.
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