How to Build and Maintain an Effective Pharmaceutical Quality Management System (Expertise in Pharmaceutical Process Technology)

How To Build And Maintain An Effective Pharmaceutical Quality Management System Shares Unique Insights On How To Improve Our Understanding Of The Human Factors Regarding Pharmaceutical Quality. It Describes Practical Ways To Improve Systems Thinking And Ways To Establish Effective Quality Management Systems. Insights Are Derived From The Author's Experience At The Us Federal Drug Administration (fda), And As A Leader Of The Fda's Pat And 21st Century Initiatives, And Finally, As An Industry Executive. The Book Describes The Fundamental Concepts And Explains How To Improve Understanding Of Qms, Particularly Focusing On The Essential Role Of Human Factors Using Real-life Examples. Utilizes Explicit Case Studies To Illustrate Ideas Throughout The Content Emphasizes Three Key Areas, Including Management, Supervisors And Staff Written By A Leader In The Field With Experience In Regulatory, Research And Technical Areas