An easy to read collection of invaluable insights from well-known GMP/Quality Systems experts edited by David Link and Ed McDonnell. You'll learn how to meet the requirements of FDA's GMP/Quality System regulation, as well as successful approaches used by practitioners with years of experience. Editor David Link was responsible for the original GMP in 1978. Since 1980, he has been helping small, medium and large medical device companies comply with the GMP requirements. Editor Ed McDonnell, a former FDA/ORA regional director, heads the quality systems division for a global drug and device consulting firm.