If the term "mangement review" conjures up visions of a wasteful and burdensome ordeal, The Management Review Handbook is just what you need to add value to your review process. The Management Review Handbook provides managers with a simple explanation of how to effectively document, implement, and maintain a management review process.Denise Robitaille's book is an excellent guide to management review for anyone involved in the process. The book's precepts hold true for any size company across a wide spectrum of industries and organizations. The tools found in the handbook can be used by top management, ISO 9001 coordinators, production supervisors, customer service managers, quality technicians, or anyone else involved in the management review process.Plus, the book includes sample forms that aid in the management review process. The forms may be photocopied. They include:* Management review agenda* Data analysis planning worksheet* Action item checklist* Customer contact form

This best-seller can help anyone whose role is to try to find specific causes for failures. It provides detailed steps for solving problems, focusing more heavily on the analytical process involved in finding the actual causes of problems. It does this using figures, diagrams, and tools useful for helping to make our thinking visible. This increases our ability to see what is truly significant and to better identify errors in our thinking. In the sections on finding root causes, this second edition now includes: more examples on the use of multi-vari charts; how thought experiments can help guide data interpretation; how to enhance the value of the data collection process; cautions for analyzing data; and what to do if one can’t find the causes. In its guidance on solution identification, biomimicry and TRIZ have been added as potential solution identification techniques. In addition, the appendices have been revised to include: an expanded breakdown of the 7 M’s, which includes more than 50 specific possible causes; forms for tracking causes and solutions, which can help maintain alignment of actions; techniques for how to enhance the interview process; and example responses to problem situations that the reader can analyze for appropriateness.

Worldwide regulatory agencies perform many inspections annually, and all too often investigation and CAPA system violations are at the top of the list of infractions. Life-sciences regulated companies (not only FDA-regulated ones) must ensure their investigation and CAPA systems look beyond the ‘usual suspects' to identify other quality issues in order to minimize risks (including safe ones) and reduce costs. Enhancements to this third edition include: A new section linking the investigation and CAPA programs with the overall quality culture of the company Fully updated, current versions of regulations including U.S. FDA, EU, ISO 9001, and ISO 13485 Updated inspectional observations from the U.S. FDA and U.K. MHRA A revised investigation and CAPA processes chapter, which has an improved barrier analysis section, including detailed flowcharts describing the barrier analysis process New charts and information related to the investigation of human errors; the human factor section includes information about training and competence A new chapter devoted to analytical laboratory investigations, including a section covering the invalidation of testing results Updated forms and examples of the different elements of the investigation and CAPA plan, including new case studies; a revised diagnostic tool used for investigating human error Jose(Pepe) Rodrguez-Perez, PhD, 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. He is a biologist with a doctoral degree in biology from the University of Granada (Spain). Over his career, he has served as an educator, a technical services manager, and as a science advisor to the FDA.

This reference manual is designed to help those interested in passing the ASQ's certification exam for Six Sigma Green Belts and others who want a handy reference to the appropriate materials needed to conduct successful Green Belt projects. It is a reference handbook on running projects for those who are already knowledgeable about process improvement and variation reduction. The primary layout of the handbook follows the ASQ Body of Knowledge (BoK) for the Certified Six Sigma Green Belt (CSSGB) updated in 2015. The authors were involved with the first edition handbook, and have utilized first edition user comments, numerous Six Sigma practitioners, and their own personal knowledge gained through helping others prepare for exams to bring together a handbook that they hope will be very beneficial to anyone seeking to pass the ASQ or other Green Belt exams. In addition to the primary text, the authors have added a number of new appendixes, an expanded acronym list, new practice exam questions, and other additional materials

The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical industry driven by consumer expectations and regulatory oversight. 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.

This updated and expanded second edition reflects the state of earth station design and ground segment architecture. From international telephone network gateways to direct broadcast home receivers, today’s broad range of ground systems and devices require satellite communication engineers and business managers to have a broad and sound understanding of the design and operating principles of earth stations and ground control facilities. This book explores the delivery end of the satellite link and its relationship to delivery of services. Authored by a leading authority in the field, the book provides engineers and managers with the knowledge they need to devise their own approach to implementing and managing earth stations and the overall ground segment. Readers find practical guidance in an array of critical areas, including: preparing requirements, performing preliminary analyses, reviewing hardware designs, managing the introduction of the overall ground segment, and more.