Due to system upgrades, asq.org will be intermittently unavailable on Monday, June 17, 2024 from 6:00 a.m. - 8:00 a.m. Central Time (CT).
| Cart Total:
Menu

Featured Book

Featured Book

Quality Risk Management in the FDA-Regulated Industry, Third Edition

José Rodríguez-Pérez, April 2024

For quality professionals and manufacturers in the food safety and medical device industries, risk management is essential to ensuring organizations meet FDA regulations and requirements. Without these recognized standards, the lives of consumers are placed in jeopardy. In this third edition of Quality Risk Management in the FDA-Regulated Industry, the author provides an updated view of the risk management field as it applies to FDA-regulated products using risk-based thinking.

Updates to this edition address:

  • How to integrate risk management principles and activities into an existing quality management system (QMS)
  • Compliance with current ISO Standards 9001:2015 and ISO 13485:2016
  • Discussion of three key and recently updated guidelines: ICH Q9(R1), ISO 14971:2019, and ISO 22000:2018

José (Pepe) Rodríguez-Pérez, Ph.D., CSSBB, CMQ/OE, CQE, CQA, CFSQA, CMDA, and CPGP, is president of Business Excellence Consulting Inc. (BEC), a Puerto Rico-based consulting, training, and remediation firm that focuses on the areas of regulatory compliance, FDA-regulatory training, and risk management. Over his career, he has served as an educator, technical services manager, and as a science advisor to the FDA. He is also the author of several best-selling books including the Handbook of Investigation and Effective CAPA Systems, Third Edition, and Human Error Reduction in Manufacturing, Second Edition, both published by Quality Press.

Member Price: $49.00

List Price: $70.00
Quality Risk Management in the FDA-Regulated Industry, Third Edition







Contact Quality Press

North America: 800-248-1946
Mexico: Mobile/cell 001-877-442-8726;
other phone 001-882-442-8726
All other locations: +1-414-272-8575
Fax: 414-272-1734
Email: [email protected]




Subscribe to Quality Press News

Our monthly e-newsletter

Become an Author

View our proposal guidelines, including current calls for authors.


New to the Store

Best Sellers

New Releases!

Human Error Reduction in Manufacturing, Second Edition (H1594)
Zero Acceptance Number Sampling Plans, Sixth Edition (H1607)
Smart Cities Framework: Reimagining the Urban Experience (H1584)
The ASQ Certified Quality Engineer Study Guide, Second Edition (H1601) 

The ASQ Certified Supplier Quality Professional Handbook, Second Edition (H1605)
The ASQ Certified Six Sigma Black Belt Study Guide, Second Edition (H1600) 
The Quality Toolbox, Third Edition (H1592)

 

Coming Soon to Quality Press  

2024 Releases:

Certification Products
The ASQ Certified Pharmaceutical GMP Handbook, Third Edition
The ASQ Certified Six Sigma Green Belt Study Guide, Second Edition (H1604)
The ASQ Certified Software Quality Engineer Handbook, Third Edition
The ASQ Certified Supplier Quality Professional Study Guide, Second Edition
The ASQ Certified Quality Technician Handbook, Fourth Edition

ASQ Products
NEW! Mastering Safety Risk Management by Jayet Moon and Arun Matthew
NEW! Leading a Quality Organization: Supercharging From Your Core
NEW! Implementing Quality 4.0 from the Ground Up
Remote Auditing Fundamentals Pocket Guide (formerly "e-Auditing Fundamentals")
The Internal Auditing Pocket Guide, Third Edition
Quality Risk Management in the FDA-Regulated Industry, Second Edition

2025 Releases:

ASQ Products
TQM: Introduction to and Overview of Total Quality Management, Second Edition
NEW! Lean Six Sigma Pocket Guide for Young Professionals


Certification Products
The ASQ Certified Quality Inspector Handbook, Fourth Edition
The ASQ Certified Reliability Engineer Handbook, Fourth Edition
NEW! The ASQ Certified Construction Manager Handbook


 

On Sale

Featured Advertisers