Pharmaceutical and Biopharmaceutical Manufacturing: Understanding Your Process Series

The U.S. FDA plans to take a risk-based approach to biomanufacturing inspection and changes are expected very soon. With regulatory expectations and the impending changes anticipated in 21CFR 600 in June 2018, now is the time to get up to date on managing risk to safely produce healthcare products!

In order to help you, we have gathered chapters from our most successful risk-based texts. These convenient, electronic texts define risk, discuss hazards and risks, provide tools to help you evaluate risk, and develop effective strategies for dealing with risk.

Written by subject matter experts, each text contains practical applications, an extensive list of international regulations for reference, and suggested PDA Technical Reports and books for further guidance.

Editors: Edwin Bills and Stan Mastrangelo

Written by experienced authors, this Volume offers insight into the risk management processes, management considerations, and strategies in product development, implementation of risk management for non-product software, and the future of risk management.

Siegfried Schmitt

This Volume offers guidance in implementing process analytical technology (PAT), discusses the challenges and pitfalls of applying a science and risk-based approach in research and manufacturing, and presents documented evidence for risk-based compliance.

James L. Vesper

In this Volume, well-respected global experts give an overview of the risk management process and the tools required, including risk-related documents and records and techniques for auditing a risk management program.

Tim Sandle

Receive expert guidance on major topics, such as regulatory perspectives on risk and five insightful case studies to help develop the best approaches to problem solving based upon the "What if" and "five whys" method.

Editors: Russell E. Madsen and Maik W. Jornitz

Sometimes even well-designed systems are thwarted by human behavior causing a series of blunders that common sense says could not have happened. In this Volume, you'll find ten examples and solutions to problems arising from failure to follow established procedures.

Editors: Russell E. Madsen and Maik W. Jornitz

This Volume discusses diagnosis and corrective actions to common problems, such as incorrect batch records, contaminated product complaints, contamination, environmental monitoring, and many other subjects.

Editors: Russell E. Madsen and Maik W. Jornitz

This Volume describes 24 problems and offers solutions regarding everything from bioburden contamination in a contained water system to filter integrity, customer complaints, process control failures, and many more real-world problems that were solved with adequate investigations.