New Book on How to Validate a Pharmaceutical Process from CfPIE’s Dr. Steven Ostrove

"How to" approach explains developing and implementing a sustainable pharmaceutical process validation program

Malvern, PA - July 28, 2016 - A new book from Steven A. Ostrove, Ph.D., senior course instructor at the Center for Professional Innovation and Education (CfPIE), provides life sciences professionals and organizations a clear approach to validating pharmaceutical processes.

In "How to Validate a Pharmaceutical Process," (US$ 42.46 Elsevier Academic Press, June 2016) Ostrove illustrates the methods and reasoning behind pharmaceutical processes and protocols. The book also addresses practical problems and offers solutions to qualify and validate pharmaceutical processes. As the author explains, 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.

Features of this book include:

  • Illustrates the most common issues related to developing and implementing a sustainable process validation program and provides examples on how to be successful,
  • Thoroughly referenced and based on the latest research and literature,
  • Covers important topics such as the lifecycle approach, quality by design, risk assessment, critical process parameters, US and international regulatory guidelines, and more.

"How to Validate a Pharmaceutical Process" can be purchased at The Elsevier Store.

Dr. Ostrove has over 30 years of experience in validation compliance, quality assurance, and regulatory affairs. His 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.

At CfPIE, Dr. Ostrove teaches three technical training courses: Good Manufacturing Practices (cGMP); Pharmaceutical and Biopharmaceutical Quality Control Laboratories - A Regulatory Compliance Primer; and Process Validation for Drugs and Biologics.

A sample of other popular CfPIE course topics include: Adverse drug events; GCP and GLP Best practices; Clinical trials; Design control principles; FDA regulatory compliance; Process validation; Quality assurance and quality control; and Technical writing.

Learn more about CfPIE’s full offering of training courses and certifications.


Tags: Validate a Pharmaceutical Process , Steven A. Ostrove