The fact that good manufacturing practice (GMP) audits in the pharmaceutical and biotechnology industries have to be evaluated, and with very limited resources,
Both internal and external GMP audits/inspections are a key requirement of Quality Management systems across medical device, biotechnology and pharmaceutical in
The life sciences industry is changing rapidly and the historical rules, regulations, government oversight are under pressure to modernize. The recent introduct
At over 400 pages, this book introduces the area of Good manufacturing and compliance for Regulated industries (Medical devices, pharmaceuticals and Biotechnolo
One of the most common reasons so many new drug, medical device, or equipment applications are rejected each year by the FDA is the failure to properly develop