This training course provides the fundamentals required to understand the methodology used to validate a computer-related system. Using step-by-step examples and interactive exercises, students are guided through the entire validation process. Practical recommendations on how to increase efficiency and ensure that validation is performed correctly the first time are used through the entire course. The concepts introduced provide a comprehensive framework for validation of computerized systems and present a logical and practical approach to the validation of any computerized system to meet both regulatory concerns and business needs within the pharmaceutical environment.

_^Outlines

• Validation Principles
• Regulators and Regulations
• IEEE (Institute of Electrical and Electronic Engineers)
• GAMP (Good Automated Manufacturing Practice)
• Validation Master Plan
• Verifications (DQ)
• Qualifications
• Custom Build Systems (GAMP Cat. 5)
• Configurable Systems LIMS, eDMS (GAMP Cat. 4)
• Shop Floor Equipment PLC, SCADA (GAMP Cat. 4)
• Off the Shelf Systems Excel Templates (GAMP Cat. 3)
• ERP Systems Validation
• with an example of SAP
• Predicate Rule and FDA 21 CFR Part 11
• FDA Regulations
• Warning Letter Summary
• Actual 483s