REGU09021 2019 Biopharmaceutical Regulation and Compliance

This module is taken by Masters students in Bioprocessing. It aims to provide students with an understanding of the risks associated with biopharmaceutical processing and how regulations translate into the manufacturing environment. It also provides students with an understanding of the main validation concepts as well as the application of continuous improvement initiatives in bioprocessing.

A BUSINESSWEEK BESTSELLER Bestselling Lean Six Sigma author Michael George provides the first pocket guide for deployers of Lean Six Sigma The Lean Six Sigma Pocket Toolbook blends Lean and Six Sigma tools and concepts, providing expert advice on how to determine which tool within a "family" is best for different purposes. Packed with detailed examples and step-bystep instructions, it's the ideal handy reference guide to help Green and Black Belts make the transition from the classroom to the field. Features brief summaries and examples of the 70 most important tools in Lean Six Sigma, such as "Pull," "Heijunka," and "Control Charts" Groups tools by purpose and usage Offers a quick, easy reference on using the DMAIC improvement cycle Provides comprehensive coverage in a compact, portable format

Time and quality are the two most important metrics in improving any company's production and profit performance. Lean Six Sigma explains how to impact your company's performance in each, by combining the strength oftoday's two most important initiatives--Lean Production and Six Sigma--into one integrated program. The first book to provide a step-by-step roadmap for profiting from the best elements of Lean and Six Sigma, this breakthrough volume will show you how to: * Achieve major cost and lead time reductions this year * Compress order-to-delivery cycle times * Battle process variation and waste throughout your organization

Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be taken for successful validation of biopharmaceutical processes. Case studies include Process validation for membrane chromatography Leveraging multivariate analysis tools to qualify scale-down models A matrix approach for process validation of a multivalent bacterial vaccine Purification validation for a therapeutic monoclonal antibody expressed and secreted by Chinese Hamster Ovary (CHO) cells Viral clearance validation studies for a product produced in a human cell line A much-needed resource, this book presents process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration. It also provides practical methods to test raw materials and in-process samples. Stressing the importance of taking a risk-based approach towards computerized system compliance, this book will help you and your team ascertain process validation is carried out and exceeds expectations.

Offers a comprehensive introduction to the principles and concepts of pharmaceutical biotechnology.

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www.fda.gov

https://www.ema.europa.eu/en

https://ec.europa.eu/health/documents/eudralex_en

www.ich.org

www.hpra.ie

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