Description
How to Validate a Pharmaceutical Process provides a "how to" approach to developing and implementing a sustainable pharmaceutical process validation program. The latest volume in the Expertise in Pharmaceutical Process Technology Series, this book illustrates the methods and reasoning behind processes and protocols. It also addresses practical problems and offers solutions to qualify and validate a pharmaceutical process. Understanding the "why" is critical to a successful and defensible process validation, making this book an essential research companion for all practitioners engaged in pharmaceutical process validation.
This essential research companion for practitioners engaged in pharmaceutical process validation features a how-to approach to develop and implement a sustainable pharmaceutical process validation program
About the Author
Dr. Ostrove has over 30 years of experience in validation compliance, quality assurance, and regulatory affairs. In addition, he has developmental and process expertise in mammalian cell culture and separation technology. His general pharmaceutical experience includes sterile techniques (Aseptic processing), Process Validation, Cleaning and Sterilization Validation, Packaging Systems, Process Development and Process Scale-up. He also has industry experience with the development and validation of PC and PLC-based computer control systems for the biotech and pharmaceutical markets, guidance on system optimization for CIP/SIP and has led teams for the review of all GMP documents starting with their preparation (e.g., protocols, SOPs, and validation master plans). Dr. Ostrove has worked on several consent degree remediation and audit teams and his experience covers both EU and US regulations. He is the author of the Elsevier short format book How to Validate a Pharmaceutical Process (Jun 2016, 9780128041482).
Book Information
ISBN 9780128041482
Author Steven Ostrove
Format Paperback
Page Count 218
Imprint Academic Press Inc
Publisher Elsevier Science Publishing Co Inc
Weight(grams) 360g
This essential research companion for practitioners engaged in pharmaceutical process validation features a how-to approach to develop and implement a sustainable pharmaceutical process validation program
About the Author
Dr. Ostrove has over 30 years of experience in validation compliance, quality assurance, and regulatory affairs. In addition, he has developmental and process expertise in mammalian cell culture and separation technology. His general pharmaceutical experience includes sterile techniques (Aseptic processing), Process Validation, Cleaning and Sterilization Validation, Packaging Systems, Process Development and Process Scale-up. He also has industry experience with the development and validation of PC and PLC-based computer control systems for the biotech and pharmaceutical markets, guidance on system optimization for CIP/SIP and has led teams for the review of all GMP documents starting with their preparation (e.g., protocols, SOPs, and validation master plans). Dr. Ostrove has worked on several consent degree remediation and audit teams and his experience covers both EU and US regulations. He is the author of the Elsevier short format book How to Validate a Pharmaceutical Process (Jun 2016, 9780128041482).
Book Information
ISBN 9780128041482
Author Steven Ostrove
Format Paperback
Page Count 218
Imprint Academic Press Inc
Publisher Elsevier Science Publishing Co Inc
Weight(grams) 360g
