System Validation, GAMP Harmonization and P.A.T
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This course is available as a client site course. Please click here for more information.
Who Should Attend
This course is designed for both users and developers of
FDA regulated systems, especially personnel involved in-
Conducting Clinical Studies
- Laboratory Analysis
- Quality Assurance
- Product Development
- Regulatory Submissions
- Information Systems
Those developing, acquiring, using, modifying, auditing,
designing, and marketing systems and devices that support
FDA regulated studies, submissions, projects and products
will also benefit.
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 best validation practices utilizing, Risk assessment,
PAT, GAMP 4 and more. Included in this comprehensive
course is:-
Validation testing, The Validation Plan, SOPs
- System Life Cycle, Hazard Assessment
- Validation Requirements of Predicate Rules including: cGMPs, GLPs, QSRs and GCPs
- ERES 21 CFR Part11, Electronic Submissions
- Disaster Planning and Business continuation, IQ, OQ, PQ
- System Security, Training Requirements, Traceability
- Source Code Vendor Review
- COTs and Shrink Wrapped Systems
- GAMP 4 and PAT
- Sarbanes Oxley
- FDA Guidance for Industry-Computerized Systems Used in Clinical Trials
The course workbook is designed to support you in class and
to be a detailed and complete validation reference guide