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Validation Documentation
Level: Fundamental
Type: Classroom Training Course
ISPE CEUs: 0.6
| Date | Location | Country | Instructor(s) |
|---|---|---|---|
| This course is not currently scheduled, but may be conducted at your company. Please contact ISPE for more information. | |||
Description
This course will provide participants with fundamental principles of validation documentation. The course will address the different types of documentation, the purpose of each document type, and how the documents are utilized by the FDA for ensuring compliance to GMPs. The course will provide samples of document types and give the student case study examples of how documents are developed and completed.
Course Modules
- Master plans (site and project)
- Protocols (Installation Qualification, Operational Qualification, Performance Qualification, Process Validation)
- Reports (Protocol Exception/Deviation, Protocol Summary)
Take Back Your Job
- Identify various types of validation documentation
- Understand the content of each document type and its importance to the validation effort
- Develop sample documents
- Review documents for accuracy and content
- Identify documents to be included in Validation Master Plans
- Execute a formal documentation review
Continuing Education Units
ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.
Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.
