Book Description

Failure to follow one's own procedures is the single most-cited violation of the Good Manufacturing Practices (GMP) regulations. In this workshop in a book, Dr. Paul Sanghera, the best selling author of several books in science and technology, presents cohesive, concise, yet comprehensive introduction to the fundamentals of Standard Operating Procedures (SOPs) in context of Good Manufacturing Practices (GMP), quality assurance, and quality control. Those who can benefit from this book include students and professionals in biotechnology, health science, and other industries: especially those who are trying to meet the FDA regulations on SOPs. This is a general book for the beginners to develop a basic understanding about SOPs. Also the busy executives and managers will find this book useful for a quick introduction to SOPs. The material is presented in the format of lecture notes, which are self-contained, comprehensive within the scope of the book, and presented in an easy-to-follow logical learning sequence. All concepts are explained from scratch with enough examples and exercises. Example SOP templates are provided to put the concepts in practical context. Topics Include: *Introduction to SOPs *Effective SOPs *Producing Effective SOPs *Living with Approved SOPs: following, monitoring, and controlling SOPs *Process Based Approach to SOPs *Solutions to Self Test Exercises * Example SOP Templates *Glossary of terms Author Bio Dr. Paul Sanghera, an educator, scientist, technologist, and an entrepreneur, has a diverse background in all the fields on which biotechnology and health sciences are based including physics, chemistry, biology, computer science, and math. He holds a Master degree in Computer Science from Cornell University, a Ph.D. in Physics from Carleton University, and a B.Sc. with triple major: physics, chemistry, and math. He has taught science and technology courses all across the world including San Jose State University and Brooks College. Dr. Sanghera has been involved in educational programs and research projects in biotechnology. He has authored and co-authored more than 100 research papers published in well reputed European and American research journals. As a technology manager, Dr. Sanghera has been at the ground floor of several technology startups. His responsibilities included process development and quality assurance at companies such as Netscape and MP3. He is the author of several best selling books in the fields of science, technology, and project management. He lives in Silicon Valley, California, where he currently serves as Adjunct Professor at California Institute of Nanotechnology.