The Validation of Computer Systems and 21 CFR Part 11
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Who Should Attend
This course will be of particular value to individuals
responsible for:
• Pharmaceutical and Biologics Manufacturing, Laboratories
• Medical Device Systems Development
• System Quality Control
• System Management and Development
• Computer System Validation
Description
The FDA’s regulation 21 CFR Part 11 has been designed and
updated to provide guidance for the use and validation of
computer systems utilized in the pharmaceutical, device, and
biological industries. The application of a testing methodology
is of particular importance in design, operation and quality
control of manufacturing and laboratory systems, where
computers are integrally used in product control and inventory
tracking.
This course is designed to provide the necessary skills for
mastering the principles and techniques of developing and
implementing a system validation and testing plan for
computer systems. The course uses a combination of
lecture/discussions, case studies, and multimedia
presentations to provide a living case of a computerized
pharmaceutical system in need of a validation plan for cGMP
information systems. The program will take participants stepby-
step through the process of developing and implementing
that plan, and will conclude with a session adapting the plan
to each participant’s unique environment and products.
Features of the Course Include:
Specification of a methodology for meeting FDA and PMA
guidelines for manufacturing systems involving computers
Practical experience in applying that methodology to actual
computerized manufacturing systems
Comparison of FDA computer guidelines with EMEA, TGA,
ANVISA, Kiro Shu, and other regulatory agencies
worldwide
New update on 21 CFR Part 11