OVERVIEW
Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. Following best practices for developing a validation program that includes planning, execution and maintenance components will ensure that these efforts will meet all regulatory agency requirements and expectations. Preparedness will improve your relationship with the agency and ensure a more cooperative and successful audit experience.
WHY SHOULD YOU ATTEND
It is not enough just to validate a computer system and defend your approach to regulatory agencies. You will also need to ensure that the data and information collected, analyzed and reported using the system can be defended effectively, as well. In this course, you will learn how to apply industry best practices to ensure that you and your system users and other stakeholders are fully prepared to defend your systems, data and information to regulatory agencies. At the same time, you will learn how to do this in the most cost-effective manner.
AREAS COVERED
- Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
- Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
LEARNING OBJECTIVES
- To understand how to prepare computer system validation documentation in preparation for an FDA audit.
- To understand the many deliverables required to complete a computer system validation effort.
- To understand industry best practices.
- To understand and avoid potential pitfalls.
WHO WILL BENEFIT
- Information Technology Analysts
- QC/QA Managers
- QC/QA Analysts
- Clinical Data Managers
- Clinical Data Scientists
- Analytical Chemists
- Compliance Managers
For more detail please click on this below link:
Email: support@trainingdoyens.com
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882
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