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.
Risk Management Library Volume 3: Practical Approaches to Risk Assessment and Management
This publication is taken from the book: Risk Assessment and Risk Management in the Pharmaceutical Industry: Clear and Simple published in 2006.
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.
Available to download. Prior to purchase please view the download instructions and Terms of Usage
Format: PDF (1 file 4.05 MB)
Table of Contents:
Click here to download >>>Detailed Table of Contents
- An Overview of the Risk Management Process (Chapter excerpted from Risk Assessment and Risk Management in the Pharmaceutical Industry: Clear and Simple, Chapter 5)
- An Overview of Risk Assessment Tools. (Chapter excerpted from Chapter 7)
- Risk-Related Documentation and Records (Chapter excerpted from Chapter 11)
- Auditing a Risk Management Program (Chapter excerpted from Chapter 18)
Current Regulations, Guidances, Technical Reports and Texts Useful for Further Reference.
About the Author
James L. Vesper designs and develops instructional courses and workshops for the pharmaceutical and medical device industries. He established and is president of the firm, LearningPlus, Inc. and has had more than 30 years experience in the pharmaceutical industry. Mr. Vesper worked eleven years at Eli Lilly and Company, Indianapolis. His last assignment there was Project Leader of GMP (Good Manufacturing Practice) Education and Instruction, establishing the department and its mission.
Since 1991, Mr. Vesper has been creating innovative instructional products for pharmaceutical firms using leader-led, video, and computer technologies as more effective and efficient delivery media. Working as consultants with a wide variety of clients, his firm creates integrated curricula for personnel and customized training courses targeted to particular needs. He provides workshops at various international technical and professional meetings. In 2001, he was awarded the PDA`s Agallaco Award for Excellence in Training. He is also the author of GMP
in Practice, Fourth Edition, becomes one of the best sellers of PDA/DHI, co-published books.
As an author, Mr. Vesper has written several books and is the principle writer on a training guideline for the World Health Organization (WHO) that was published in 2007. He continues to work with the WHO as a consultant and advisor to WHO's Vaccine Quality/Global Learning Opportunities.