System Validation, GAMP Harmonization and P.A.T Training Course :

Who Should Attend
Learning Objectives
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
01/01/0001 To 01/01/0001
Training Company
The Center for Professional Advancement (CfPA)
Industry
Clinical Research Organization
Course Category
Address
New Brunswick, NJ New Brunswick,