1st Edition
How to Sell Validatable Equipment to Pharmaceutical Manufacturers
By Erik Kopp
Copyright 1999
366 Pages
by
CRC Press
Suppliers of pharmaceutical manufacturing equipment must ensure that their equipment is provided to their customers in a validatable state. Written in simple, clear, and concise language that gets past all the regulationese, this book covers the basics of validation, planning process equipment design and construction, documentation requirements, avoiding validation pitfalls, and the types of... Read more
Introduction, 1 The Basics: The Regulations in Plain Language, 2 A (Very) Simple Validation Example, 3 Why Is Validation So Confusing? 4 What to Be Aware of Before Working on a Job for the Pharmaceutical Industry 5 Providing Validatable Equipment: The Role of the Equipment Supplier 6 Pharmaceutical Industry Requirements for Process Equipment Design and Construction 7 Validatable Computer Systems 8 Documentation: The Foundation of Good Manufacturing Practices 9 The Turnover Package 10 Providing Added Value Without a Lot of Extra Work 11 Validation Hang-Ups: What to Watch Out for and How To Avoid Them 12 Validation Services Performed by Equipment Suppliers 13 Conclusion
Biography
Erik Kopp (Flemington, New Jersey, USA)
