Edwards Deming, the famous pioneering leader of Toyota in the mid-1900s, widely regarded as the Father of Modern Quality, said: “85% of the reasons for failure are deficiencies in the systems and process rather than the employee.” Many studies place that number at 95%. This course challenges traditional thinking on what causes, and how to prevent, errors and deviations, and helps transform organisations from looking for people’s errors to finding system flaws and harnessing people for solutions.
HEP is a well-researched, well documented field adopted by many industries (eg. aerospace, nuclear) decades ago. This highly interactive course provides practical tools and strategies for preventing deviations, rather than writing and closing them faster. It focuses on practical application without the need for costly equipment/facility changes, software, validation or even change control in most cases.
The course includes an overview of key definitions, importance, human error causes, and myths vs. facts across industries to provide strong foundational knowledge and background. It then focuses on the many risk factors present in the biopharma/device industry and goes through the top causes of, and strategies for preventing, human errors in this fast-paced, error prone environment. The course then focuses on specific application and practical HEP tools and implementation best practices to help attendees apply the learning at their firms.
This interactive course includes audience questions and polling, activities and exercises to help participants apply and retain the knowledge.
Who Should Attend
This comprehensive 20-hour course will be valuable to all personnel working in a GMP manufacturing environment, including Manufacturing, Quality Control, Quality Assurance, Quality Systems, Supply Chain, and Facilities and Engineering employees. It will benefit individual contributors, supervisors, area managers, and leadership decision makers, especially those involved in frontline operations, deviation management, investigators, continuous improvement, and operational excellence.