Hello, Optima Training has detected that you are using an outdated version of Internet Explorer. If possible we strongly urge you to update your browser or switch over to Chrome or Firefox so you can enjoy the full user experience of our website and avail of all the features!
Close This Message'

Equipment Validation

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.

Product Code:
QH13
Duration:
2 Days - 01/12/2022 & 02/12/2022
Times:
09:30-16:30
Cost Includes:
Training course materials and after-training support
Contact Name:
Fionnuala Landers
Venue:
Limerick
Date:
X €695
Make an Enquiry
Attendee(s), if more than one seperate with a comma
Course Content
Intended Audience
Method Of Delivery
Reviews

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

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.

There are no reviews yet.

Be the first to review “Equipment Validation”