Description
Recent problems associated with computer inaccuracies have
led the FDA to pressure the pharmaceutical and blood
processing industries into adoption of rigid standards of
system validation and testing. The application of a testing
methodology is of particular importance in design, operation
and quality control of manufacturing systems, where
computers are integrally used in product control and inventory
tracking.<br><br>
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
manufacturing-related computer systems. The course uses a
combination of lecture/discussions, case studies, “role-play
actors,” 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 step-by-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.<br><br>
<b>Features of the Course Include:</b><ul><li>
Specification of a methodology for meeting FDA and PMA guidelines for manufacturing systems involving computers</li>
<li>Practical experience in applying that methodology to actual computerized manufacturing systems</li>
<li>New update on 21 CFR Part 11</li></ul>
