ISA-88 and ISA-95 in the Life Science Industries
Momentum Press is proud to present the fourth volume of the WBF series, ISA-88 and ISA-95 in the Life Science Industries. Written by experts from companies such as Pfizer, Merck, Genentech, and Amgen, the book explains the use of these standards to reduce design, implementation and training problems unique to these industries.
The life science industries make products that directly affect the health of people. They are regulated by government agencies to assure that products are safe and effective, and that manufacturing processes will not vary in ways that affect product quality. Many of the chapters in this book address that very same verification and validation of products and processes. Other chapters describe ways to shorten new product development time—from identification of a need for a new process to actual production of products. In addition, case studies and implementation experiences further describe ways to get the most from the ISA standards in the book’s title.
You will find incredibly valuable information in chapters such as:
- ISA-88 Provides a Framework for a Pharmaceutical Process Module Library
- ISA-88 Design and Implementation Case Study for a Complex Bulk Pharmaceutical Batch Process
- Batch On-line Analytics: A Solution Beyond Six Sigma
- The Road to Full MES Integration: Practical Experience from the Pharmaceutical Industry
- Risk-based Engineering Assessment and Qualification: A Case Study
- Multiple Products in a Monoclonal Antibody ISA-88.01 Batch Plant
- Using General Recipes for Standardized Multiple Plant Manufacturing Science
- Manufacturing Science Model Extensions to Address Quality by Design and Risk Assessments
Concerned about your manufacturing operations? Looking to improve process efficiency and productivity? Let the four books in the new WBF series being published by Momentum Press show you how to apply the ISA-88 and ISA-95 standards.
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