Equipment Validation

Course Content:

Using a series of formal presentations, combined with various practical exercises and case studies, the workshop is designed to be interactive, and so promote understanding of validation, with focus on Equipment Validation.

• Introduction
• Business Benefits of Equipment Validation
• Regulatory Requirements & Guidelines
• Validation Master Plan

•Validation versus Verification
• Statistical Methods & Tools for Validation
• ISO 14971 & Risk Assessment

• Equipment Qualification (IQ, OQ, PQ)
• Cleaning Validation
• Product & Process Validation
• 21 CFR Part 11 – Electronic Signatures & Records
• Case study & exercise
• Preparing a Validation Master Plan
• Preparing a Equipment Validation Protocol
• Preparing a Process Validation Report

• Maintaining a state of validation
• Retrospective Validation
• Review of recent FDA Warning Letters