Temple University 3 credits QARA
This course studies the regulatory history and background for computerized system validation (CSV). The current FDA and global CSV relevant regulations including the predicate rules will be discussed. The course will also address compliance with 21 CFR Part 11. The course will introduce students to software development methods and deliverables as they relate to CSV. A wide range of computerized systems typically employed in regulated environments will be examined and their unique challenges will be discussed. Students will have the opportunity for hands-on practice in the development of key validation deliverables and will complete an assigned project. Software development experience is not needed, but a better than average understanding of technology and the systems used in Life Sciences is expected. Not open to students who have taken QARA 0498.
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