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Overview: This course provides clarification of the competencies to plan effective, efficient and thorough investigations and design a process for the successful elimination of recurring failures and deviations. The material will examine the investigation process from failure identification and notification through documentation, describe various analysis techniques to help you visualize the problem, and reveal the number one skill, as well as common pitfalls, in reaching correct root cause. The primary objective of this course is to demonstrate the value of conducting proper root cause analysis as part of your investigation system. Emphasis is placed on application and how to facilitate root cause analysis. This course will be practical in its application and particularly valuable to those newer to this field or those who wish to refresh their knowledge of root cause analysis and investigative techniques. Why you should attend: Inadequate failure investigations continue to be a major GMP deficiency cited within routine and for-cause regulatory inspection reports from both the FDA and EU regulatory agencies. More and more firms continue to operate with an unsuccessful approach to the failure investigation process and, subsequently, do not conduct an efficient or effective root cause analysis. As a result, in a majority of companies, the common and significant root cause is being improperly reported as human error. Consequently, the same deviations continue to recur; processes become non-productive due to unidentified equipment malfunctions, along with employee distrust. Areas Covered in the Session: Phases of an investigation Definition and Principles of Root Cause analysis Skills of an Investigator The Interview Problem Solving Problem Statement Root Cause Analysis Tools Barriers and Controls Who Will Benefit: Persons who have the role of Investigator Persons who have the title of Investigator Investigation Team Facilitator Kerry gained his pharmaceutical manufacturing experience during his 28-year career with Merck. His career spanned the areas of Quality Operations, Audits & Inspections, Laboratory, Human Resources, and Learning & Development. More specifically, his responsibilities included quality management of laboratory assessment, site GMP lead auditor, FDA QSIT/Quality Management System manager, 5S coordinator, GMP trainer (annual, ongoing, new hire), OSHA regulations and Process Safety Management training, as well as internal and external public relations. Kerry is a graduate of James Madison University in Harrisonburg, VA (B.S. in Chemistry) and is an advanced Toastmaster. He has received qualifications and certifications in the areas of facilitation and training, including competency-based curricula. His past affiliations have included ASQ, ASTD, PDA, GMP-TEA, ASPI, and AQP. Kerry is the founder of Summit Consulting, Inc. and has been assisting firms in the areas of remediation and project management within the manufacturing and the laboratory functions for the past two years. AMAZINES.COM
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Online Training, Root Cause Analysis, RAPS, RAC, FDA and EU, Investigator,
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