How to Sell Validatable Equipment to Pharmaceutical Manufacturers

ISBN-13: 9781574910971 / Angielski / Twarda / 1999 / 368 str.

Erik Kopp; Kopp Kopp

Opis

While compliance with FDA validation regulations are technically the worry of pharmaceuticals and biotechnology manufacturers, equipment manufacturers and suppliers can sell more if they are aware of the regulatory environment within which their customers operate. Chapters discuss the basics of vali

Spis treści

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

O autorze

Erik Kopp (Flemington, New Jersey, USA)