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Validation Documentation
Learn the fundamental principles of validation documentation including different types of documentation, the purpose of each, how they are utilized to ensure compliance and how to utilize basic engineering documentation in support of qualification. Students will learn and discuss the tools available to conduct computer, equipment, facility or utility assessments in order to determine qualification requirements. A general overview of installation, operational and performance qualification protocols will be provided. Students will also learn and review guidance documentation provided by Boards of Health and the industry. The course includes several exercises that illustrate concepts and enhances understanding.
This course may be taught at any location.
Level: Intermediate
Lecture Hours: 6.00
Lab Hours: 2.00
Total Contact Hours: 8.00
Topics Include
This 1 day, 8 hour course covers the following topics:
- History of Validation
- Overview of current guidance documents
- Engineering and Validation Documents
- Assessment tools
- Qualification tests and procedures
- Documentation practices
- New validation trends and developments
Learning Objectives
Upon successful completion, participants will be able to:
- Accurately record field measurements in a protocol
- Conduct a peer review of a protocol
- Describe the history of validation and the guidance information
- Identify various types of engineering and validation documents
- Describe the content of each document and its importance to the validation effort
- Explain the engineering and validation life cycle approach
- Review and describe current documentation practices
Audience
Quality Assurance, Quality Control, compliance and regulatory personnel who have validation responsibilities will benefit from this course. The class is also designed for individuals seeking industry training in developing validation programs and protocols.
