What Will You Learn?
Upon the completion of this book you will be able to understand the basic difference between validation & qualification terms, discuss the principles of equipment qualification, understand regulatory requirements and expectations, understand impact based qualification need assessment approach, understand risk Based equipment qualification approach, understand equipment qualification documentation and much more…
Who Should Read This Book?
At around 70 pages, this book is an easy read. As you move through the book you’ll quickly notice that it’s written in a clear tutorial format that’s easy to understand. If you hate wading through dry “academic-style how to” texts, this book will be a breath of fresh air to you. If you want to learn about equipment qualification or want to brush up on your current knowledge this book is made for you! We’ve broken down this book into 24 key sections:
- Terms Explained
- Qualification versus Validation
- What are the Benefits of Equipment Qualification?
- Qualification Planning
- Risk Based Impact Assessment - Qualification
- Need Assessment
- User Requirement Specification (URS)
- Risk Assessment
- What is FAT/SAT?
- Equipment Design Qualification (DQ)
- Equipment Installation qualification (IQ)
- Equipment Operational Qualification (OQ)
- Equipment Performance Qualification (PQ)
- Requalification
- Change Control
Why Buy from AskaboutValidation?
Of course, we’re so confident that you’ll be happy with this book for years to come that we’re happy, as always, for you to try it risk-free for 30 days. If you purchase a copy of An Easy to Understand Guide to Equipment Qualification and you think it falls short of being everything you wanted, we’d like you to have your money back. Simply contact us and we’ll see to it that you receive a prompt refund of the full purchase price, minus shipping and handling. What could be fairer than this?
About the Author
Joginder Mittal M.Sc (Microbiology); MBA, is a pharmaceutical GMP Expert with years of extensive experience in cGMP aspects required during designing and setting up of Manufacturing Plants / Laboratories / R & D units. He has been involved in various projects for qualification activities, setting up of Quality Management System, GMP Audits and GAP Analysis.
He has handled the projects for Multi Product Oral Solid Dosage Manufacturing Facility, Large Volume Parenteral Facility, Small Volume Parenteral Facility and Consumer Healthcare Product Facility. His validation experience includes development of Facility Risk Management Plan, Validation Master Plans, Risk based Equipment Qualification, Validation Protocols Package for Facility, Process, Utilities and Computer System Validation (GAMP 5).
Contact Us
If you would like to learn more about this book, before you purchase you can email us directly at books@askaboutvalidation.com or call us now on +353-1-443-4016 Looking forward to hearing from you!
