This Equipment Validation training course is a 2 Day public programme, designed to provide participants with basic principles of validation with focus on equipment validation.
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.
• 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
This Equipment Validation training programme may be of interest to all personnel directly involved in equipment validation, as well as, new or seasoned operational personnel who will eventually participate in such efforts. Individuals in management who interact with the above or interact with regulatory agency inspectors to rationalise or defend validation programs will also benefit from attending this course.
Classroom based, instructor lead, practical hands on course.