There are best practices associated with testing methodologies used in the FDA-regulated arena, and these can be used to develop a standard and consistent approach within a company. Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacture, testing, distribution and management of a product in the pharmaceutical, biotechnology, medical device, animal health, tobacco and other regulated industries. Testing is a key aspect of computer system implementation, validation and all activities related to the system development life cycle (SDLC). As such, there are specific deliverables and key tasks that must be completed in accordance with FDA requirements.
Hear from our Speaker
Why should you Attend?
The Learning Objectives of this Session are:
Who will benefit?
This webinar will also benefit any consultants working in the tobacco or life science industries who are involved in computer system implementation, validation and compliance.
Carolyn Troiano has more than 35 years of experience in computer system validation and compliance in the pharmaceutical, medical device, tobacco and other FDA-regulated industries.
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