Who Should Attend

This course is intended for all personnel concerned with quality and the analysis & correction of problems.  The material presented will be of value to varying levels of expertise among the participants, and will be pragmatic in emphasis.  It will be particularly valuable to those newer to this field or those who wish to refresh their knowledge of these technologies.



Learning Objectives

Upon completion of this course, participants will have gained an understanding of the basic concepts involved in Root Cause Analysis and the tools used to conduct this activity.  Participants will learn through experiential activities such as group discussions, role-plays, games, and case studies tailored to regulated industries.



Course Description

The primary objective of this course is to develop an understanding of the principles and techniques involved in the practice of Root Cause Analysis.  Emphasis is placed on the practical aspects of how to perform an analysis.  In addition, this course will provide effective methods which can be used with a Corrective Action system to helps you and your team to ensure costly issues are resolved quickly and do not get dropped through the cracks. 

The course will provide attendees with a system to categorize all types of issues, assign responsibility and track team activities to resolve important issues.

Attendees will also learn advanced skills in root cause analysis, problem prevention, and continuous improvement.  Included will be the identification of the characteristics and changes that have contributed to simple and complex problems and how to fix them, as well as, working with the tools and templates to capture all needed data to comply with CAPA reports.

Topics to be covered include:

• Efficient root cause analysis programs
• Developing effective training programs to ensure compliance
• Responding effectively to non-conformances, failures, deviations and complaints by identifying root causes and implementing corrective and preventative actions
• Developing and implementing programs to prevent reoccurrence
• Essential SOPs and Other Documentation
• Understanding and interpreting OOS results
• Increasing accuracy through efficient documentation practices
• Areas of FDA concerns
• Identifying and tracking deviations and non-conformances
• Responding to complaints and deviations with corrective and preventative actions
• Learning to analyze and trend data to identify existing and potential causes of non-conformance
• Integrating RCA with other systems: internal auditing, CAPA and complaint handling
• Gathering, organizing and managing the data required to conduct RCA
• Determining whether or not a complaint should go through a CAPA program
• Determining internal and external reporting requirements
• Writing effective SOPs
• Verifying and validating a CAPA program
• Performing trend analysis and using effective RCA tools (Flow Charting, Fault Tree Analysis, Fishbone Diagrams, etc.)
• Optimizing CAPA and RCA documentation procedures
• Analyzing FDA Warning Letters and common citations to avoid non-compliance

“This course has the information to take you to the next level.  CAPA and Root Cause can effect each company at a different level. I am extremely pleased with the knowledge that I am taking back with me.” 
Donna C., Manager of QA and RA, Positron Corporation

“I believe this was a very good experience.  The course contained very helpful information and provided me with tools to better understand CAPA.” 
Roman M., CAPA Coordinator, Tyco Healthcare

“Great instructor!  Well schooled.  Teaches well.  Personable.  Keeps the class interesting.” 
Mike P., VP, Director of Operations, Celeste Ind. Corp.

“The instructor is knowledgeable and explains the subject very well.” 
Meliha M., Quality Engineer,  DePuy Spine, Johnson & Johnson

“The instructor was excellent.  She was extremely knowledgeable in the subject matter.  I would recommend that anyone who deals with CAPAs take this course with her.  Wonderful teacher.  I cannot express that enough!” 
Jennifer B., Quality Specialist, Sanofi Pasteur

“Case study was an excellent method to apply what you learned and working in a team environment was a good exercise.  The quantity of work and presentation was good and the right amount of interaction between attendees made the training interesting and beneficial.  It is a good basic information course for introducing CAPA and RCA analysis.  I recommend the course to any GMP compliance related personnel.” 
Jennifer L., GMP Compliance Manager, Wyeth Pharmaceuticals