Description
This course is designed to provide the basics of computer
system validation. Utilizing lectures, discussions, hands
on exercises, the class will address the rules, tools and
techniques needed to develop, manage, and conduct a
validation process and project. The program focuses on
the <i>best validation practices</i> utilizing, Risk assessment,
PAT, GAMP 4 and more. Included in this comprehensive
course is:<ul><li>
Validation testing, The Validation Plan, SOPs</li>
<li>System Life Cycle, Hazard Assessment</li>
<li>Validation Requirements of Predicate Rules including: cGMPs, GLPs, QSRs and GCPs</li>
<li>ERES 21 CFR Part11, Electronic Submissions</li>
<li>Disaster Planning and Business continuation, IQ, OQ, PQ</li>
<li>System Security, Training Requirements, Traceability</li>
<li>Source Code Vendor Review</li>
<li>COTs and Shrink Wrapped Systems</li>
<li>GAMP 4 and PAT</li>
<li>Sarbanes Oxley</li>
<li>FDA Guidance for Industry-Computerized Systems Used in Clinical Trials</li></ul>
The course workbook is designed to support you in class and
to be a detailed and complete validation reference guide