Technical & Academic Works

Each chapter stands alone, and the chapters may be read in any order. Some material reaching beyond the content of the BOK has been added. Supplemental reading suggestions are provided.

This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.

The chapters and sections are numbered by the same format used in the Body of Knowledge (BoK) for the CRE examination. It also includes a comprehensive glossary of reliability-related terms and appendices with, among other things, various useful distribution tables.

The ASQ CSSBB Study Guide

This book is primarily meant to aid those taking the ASQ Certified Six Sigma Black Belt (CSSBB) exam, and is best used in conjunction with The Certified Six Sigma Black Belt Handbook. Section 1 provides 432 practice questions organized by the nine parts of the 2015 Body of Knowledge (BoK). Section 2 gives the reader a 150-question practice exam comprising each of the nine parts of the BoK, in a randomized order that simulates the actual certification exam. Unlike other resources on the market, all these questions and solutions were developed specifically to address the 2015 CSSBB Body of Knowledge and help those studying for the certification, including considering the proper depth of knowledge and required levels of cognition.

The accompanying CD contains 180 supplementary problems covering each chapter and a 150-question simulated exam that has problems distributed among chapters per the scheme published in the BOK. New to this edition, the problems are now fully worked so that readers can more readily follow the problem-solving process.

The CD-ROM has been expanded into two disks, and a layout diagram is available in Appendix R. Given that this is an electronic format, you are encouraged to search the files for any number of forms, examples, templates, videos, and other useful tidbits that can help in running projects and preparing for the exam.

The ASQ CSSGB Study Guide

A team of ASQ Fellows has created this study guide with over 300 new questions predominantly based on the best-selling second edition of The Certified Six Sigma Green Belt Handbook.

The primary audience for this work is the individual who plans to sit for the ASQ Certified Six Sigma Green Belt (CSSGB) examination. The intended purpose of this study guide is to help you determine your readiness for the exam, using the questions as a self-assessment tool.

The answers to each chapter’s questions appear at the end of the chapter. The correct answer is given by letter, along with the location of the topic and page number and paragraph (or other locator) in the second edition of The Certified Six Sigma Green Belt Handbook.

The CD-ROM has been expanded into two disks, and a layout diagram is available in Appendix R. Given that this is an electronic format, you are encouraged to search the files for any number of forms, examples, templates, videos, and other useful tidbits that can help in running projects and preparing for the exam.

The CD accompanying the print book and at the end of the e-book versions includes a practice problem set covering each part of the book and a simulated examination that has problems distributed among parts according to the scheme published in the Body of Knowledge.

The ASQ CSSYB Study Guide is primarily meant to aid those taking the ASQ Certified Six Sigma Yellow Belt (CSSYB) exam and is best used in conjunction with The Certified Six Sigma Yellow Belt Handbook. Section 1 provides 151 practice questions organized by the five parts of the Yellow Belt Body of Knowledge (BoK) effective from March 2015 until March 2021. Section 2 gives the reader 136 additional practice questions from each of the five parts, in a randomized order. For every question in both sections, detailed solutions are provided that explain why each answer is the correct one and also which section of the BoK the question corresponds to so that any further study needed can be focused on specific sections. The provided solutions are taken from the same references used by the ASQ Item Writing teams who create the test items used in the formal Six Sigma Yellow Belt Certification examination.

The chapters and sections are numbered by the same format used in the Body of Knowledge (BoK) for the CRE examination. It also includes a comprehensive glossary of reliability-related terms and appendices with, among other things, various useful distribution tables.