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How to implement an effective Root Cause Analysis and CAPA Program; A close loop approach

How to implement an effective Root Cause Analysis and CAPA Program; A close loop approach

CourseDirector Course Director: Jackelyn Rodriguez

CourseCost Course Cost | Ubicacion1 Course Location | Date Course Date

Amsterdam | November 2 - 3

$1450.00 Regular Registration / $1300.00 Early Bird (30 Days in Advance)
DoubleTree by Hilton Hotel Amsterdam - NDSM Wharf 
NDSM-Plein 28
Amsterdam, 1033 WB

China | December 4 - 5

$1450.00 Regular Registration / $1300.00 Early Bird (30 Days in Advance)
Hilton Shanghai Hotel 
No 250 Hua Shan Road
Shanghai, 200040

CourseBrochure Aditional Course List: Click here

Course Description

CAPA is the most frequently cited process in FDA 483 and Warning letters. In 2014, the FDA issued 360 483s against the CAPA system. They found deficiencies in procedures, effectiveness, investigations, and timeliness.
Join MQSS — August 21-22, 2017 in San Jose Costa Rica — for an in-depth discussion on how to improve your skills in performing investigations and identifying effective CAPAs by understanding the underlying “whys” and “how-tos” for implementing a robust Compliant CAPA program

Workshop includes:
Learn how to implement a effective 9 Step CAPA program
  • Discuss the expectations that GMP regulatory authorities have of investigations, CAPAs and investigation reports
  • Describe how accident/incident models can be used when conducting an investigation
  • Differentiate between root cause, contributing causes
  • Discuss why human error is not a valid root cause
  • Discuss a model that can be used to illustrate multiple layers of control and mitigation
  • Identify the different sections of an investigation report and what each section should include
  • Linkage of Risk Management to investigation levels
  • Gain valuable strategies for getting information right away in the “golden hours” after the incident.
  • Discover best practices for determining the real cause of human error with tools
  • Benchmark current best practices in CAPA and investigations with your peers..
  • Obtain sample forms for conducting investigations and case reviews.
  • Understand the four components of a well-written report and Identify better ways of finding the real reasons behind the category of “human error” — and ways to better control and mitigate those factors.



Module 1. Overview of the Quality System Requirements and cGMPs for Root Cause & CAPA! FDAs Current Inspection practices: FDA’s QSIT + CAPA Inspectional Approach

  • FDA Quality Systems Inspection Technique and CAPA (21 CFR 820.100 and 21 CFR 211.180) Introduction to Root Cause Analysis (RCA) and Corrective and Preventative Action (CAPA)

Exercise/Review: CAPA Requirements Applicability Overview

Module 2. Introduction to Root Cause Analysis (RCA) and Corrective and Preventative Action (CAPA)

  • Define the different types of actions: corrective, preventive and remedial Describe the "closed loop" CAPA approach

Exercise: CAPA Requirements Applicability Overview Develop and Implement an Effective CAPA Program List the sources of data involved in a CAPA program Exercise: Review of case scenario

Module 3. Problem definition and Data collection and Risk Ranking to determine levels of investigation

  • Identification of the problem
  • How to write a complete problem statement Effective Data Collection
  • Remedial Actions
  • The potential impact of the problem, the actual risks to the user, the company, customers and potentially patients
  • How to effectively apply Risk Assessment in order to determine levels of investigation Describe the process of risk ranking and discover how to use trends early
  • Identify the extent of product or quality problems
  • List the sources of data involved in an investigation process

Exercise: Based on the Identified Nonconformance issues. Write Problem statement (using the Ws and the Hs). Assign Risk level to problem statement

Module 4. The Challenges of Root Cause Analysis Investigations

  • Evaluation of the problem vs. Investigation Determining the Whys..
  • Human Error analysis Preventing Human error
  • Continuous improvement models: 5S Utilize event/RCA flow charting

Exercise: Review of case study using event/RCA flow charting

Second Day

Module 5.  Examine Methods for Understanding and Determining Root Causes

  • Review the basic principles of root cause analysis
  • Recognize root causes to respond to non-compliances, failures, deviations and complaints Recognize frequent types of non-compliance
  • Evaluate common categories of root causes and contributing causes Change Control Barrier Analysis

Exercise: Case Analysis case study

Module 6. How to Conduct Root Cause Analysis (RCA) by effectively using RCA tools

  • Introduction of Root Cause Analysis tools
  • Examine Ishikawa diagrams/Cause & Effect Diagrams (Fish Bones) Perform trend and other program analyses such as:
  • Why Diagrams Control Charts Check Sheets Scatter Plots Pareto Charts
  • Process Flow Diagrams Explore Fault Tree Analysis

Exercise: Based on the Identified Nonconformance issues (from problem statement) List data needed for the data analysis phase

Exercise: Perform RCA using a Fish Bone -Apply 5 W Techniques to report determine: Root Cause

Module 7. Validate Effectiveness of Corrective and Preventive Actions

  • Developing a CAPA Action Plan
  • Determine if the corrective and preventive actions were effective Verify and validate the CAPA program
  • Track changes in CAPA

Module 8. Preventive Action, and the linkage to Risk Management Practices

  • Review Industry Practices in Quality System Regulation CAPA verifying and validation practices, preventing recurrence of non conforming product, failure investigation.
  • Identifying Common Root Causes using an FMEA and Implementing Corrective Actions And Preventive Corrective Actions as a result

Exercise: Participants will generate a process FMEA

Learning Objectives

This course provides clarification of regulatory expectations and guidance, and the essential skills necessary to ensure effective and efficient investigations. Topics will examine each step of the investigation process from failure identification and notification through documentation.. Participants will practice root cause analysis techniques and identify corrective and/or preventive actions towards successful effective remediation and closeout.

Attendees will gain a perspective of effective interviewing and writing skills, discuss common pitfalls, and develop tips and techniques for thorough investigations and elimination of recurring failures and deviations. Additionally, attendees will learn through hands-on activities such as group discussions and case studies tailored to regulated industries.

Who Should Attend

This Root Cause Analysis training course is designed for personnel who are responsible for the failure and deviation investigation process in a GMP environment, specifically Root Cause Analysis for CAPA. These include, but are not limited to, positions in Manufacturing and Packaging, Quality Assurance/Quality Control, and those support groups who initiate, conduct and/or manage investigations in a pharmaceutical, clinical manufacturing, biologics and medical device environment. 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.

For more information, click HERE

All of course can be delivered on-site and can be fully customizable


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