Presale! Quality Risk Management: A Practical Guide
- Published
- Jan 2025
- ISBN
- 978-1-917195-12-6
- Pages
- 375
- PDA Item Number
- 43574
- Format
- PDF Single User
- Member Price
- $230.00
- Nonmember Price
- $230.00
- Government Price
- $230.00
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**PRE-SALE! Full title will be released on 1/6/2025.**
Since the publication of the first Quality Risk Management (ICH Q9) guideline in 2005 and the Risk Assessment and Risk Management in the Pharmaceutical Industry: Clear and Simple book by James Vesper in 2006, the pharmaceutical industry has made considerable strides in its understanding and application of QRM and risk-based thinking. This evolution is captured in a revised and expanded volume, Quality Risk Management: A Practical Guide. Beginning with a historical context of some key events that have shaped how we as a society and industry think about risks and controlling them along with defining concepts and terms, the authors provide an overview of the QRM Q9(R1) model and do a deeper dive into each of the QRM phases. An emphasis is made on risk-based thinking and bias reduction. Various methods and tools used in doing risk assessments are described illustrating that risk management is more than just using a singular tool like failure mode effects analysis (FMEA). In eighteen chapters and nearly 350 pages the authors provide all the information you need to understand the concept of QRM, including chapters on facilitating risk management activities and the connection between risk management and knowledge management.
QRM is an essential aspect of the pharmaceutical industry and this volume is based on the authors’ experience as facilitators, risk-tool developers, and instructors to pharma and biopharma risk teams around the world. Quality Risk Management: A Practical Guide will prove an important and key resource for risk owners, risk assessment facilitators, quality unit leaders, and those who make risk-based decisions.
The full list of chapters is as follows:
- An Incomplete History of Risk Management
- Concepts and Terms Defined
- How We Think About Risk
- Accident Theory
- An Overview of the Quality Risk Management Process
- Risk Communication
- Risk Review and Monitoring
- Risk-based Decision Making and Methods
- An Overview of Risk Assessment Tools
- Preliminary Hazard Analysis / Preliminary Risk Analysis
- Failure Mode Effects Analysis
- Hazard Analysis and Critical Control Points
- Fault Tree Analysis
- Risk-Related Documentation and Records
- Facilitating Risk Assessments – Virtual and Face-to- Face
- Evaluating a Risk Management Program
- Risk Management and Third Parties
- Risk Management and Knowledge Management
Table of Contents
Chapter Headings
- An Incomplete History of Risk Management
- Concepts and Terms Defined
- How We Think About Risk
- Accident Theory
- An Overview of the Quality Risk Management Process
- Risk Communication
- Risk Review and Monitoring
- Risk-based Decision Making and Methods
- An Overview of Risk Assessment Tools
- Preliminary Hazard Analysis / Preliminary Risk Analysis
- Failure Mode Effects Analysis
- Hazard Analysis and Critical Control Points
- Fault Tree Analysis
- Risk-Related Documentation and Records
- Facilitating Risk Assessments – Virtual and Face-to- Face
- Evaluating a Risk Management Program
- Risk Management and Third Parties
- Risk Management and Knowledge Management
About the Authors
James Vesper
James Vesper designs and develops instructional courses and workshops for the pharmaceutical and biopharma industries at ValSource, Inc. He has had more than 40 years’ experience in the pharmaceutical industry, including eleven years at Eli Lilly and Company. His areas of interest include GMPs, contamination control, Quality Risk Management, root cause investigations, knowledge management, and learning & performance solutions.
Dr. Vesper has written six books. He has taught at the PDA Training and Research Institute, has been co-lead for PDA task force on knowledge management and spoken at PDA Annual Meetings, PDA/FDA Joint Conference, IMRP, and the Association for GXP Excellence and taught in-house courses for a wide range of international clients including WHO and PIC/S.
Dr. Vesper has a BS in biology (Wheaton College), an MPH (University of Michigan School of Public Health), and a Ph.D. in Education (Murdoch University, Perth, Western Australia).
Amanda McFarland
Amanda McFarland is a Senior Consultant with ValSource, Inc., where she specializes in the design and implementation of CGMPs, Quality Systems, Microbiology, and Quality Risk Management programs. She is a recognized expert in developing risk management training programs, integrating risk management into quality systems, and facilitating risk-based strategies tailored to the unique needs of the pharmaceutical and medical device industries. With a career spanning various leadership roles, Amanda has successfully spearheaded initiatives that foster a proactive, risk-based decision-making culture across global organizations. She is active in PDA, serving on the RAQAB and speaking at international, national, and regional PDA events.
Amanda holds a Master of Science in Mycology and a Bachelor of Science in Entomology, from the University of Florida. Her academic foundation complements her professional expertise in quality risk management and contamination control.