Root Cause Analysis: Foundation of Investigations and CAPA

Course "Root Cause Analysis: Foundation of Investigations and CAPA" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

Why you should attend:

• What do the regulations say?
• Four Phases of RCA
• Promote the ability to provide problem-solving support in situations where one is not an expert in the process or technology involved
• Expand the range of tools available for analysis of problem situations
• Apply a variety of tools to narrow down the possible causes of a problem
• Learn how to investigate serious and complex incidents and events
• Learn the importance of near-miss investigations, incident classification, and data trending
• Learn how to identify root causes (not just causal factors) using proven techniques
• A robust investigation and root cause analysis process, as well as, basic root cause analysis tools that can transfer to any company
• Understanding of the major cause categories that can affect your processes - and which categories tend to be the most overused and underused
• How to identify whether you’re finding the direct or the root cause of a problem
• The ability to identify the true cause of an issue and, as a result, identify and implement more effective CAPAs
• Tips for implementing a root cause analysis training program at your facility - and what support is required for the process to work once people are trained
• Apply performance management concepts in case studies with a focus on prevention and issues management
• Recognize components of effective corrective action planning and documentation
• Identify examples of corrective action planning for different site noncompliance case scenarios
• Discuss successful preventive action planning and implementation
• Develop, establish, implement, and maintain effective root cause analysis and CAPA procedures and other documentation
• Discussions on proper CAPA system maintenance, documentation of the Corrective and Preventative Actions and developing a robust CAPA plan
• Attendees are encouraged to bring examples of their work from the functional area on the various topics as applicable for group discussion
• Challenges and possible solutions will be discussed, and examples will demonstrate how the requirements can be put into practice
• Review and discuss pain points, challenges and solutions
• Are you in compliance with the FDA Corrective and Preventive Action (CAPA) requirements?
• Do you know how to identify root cause and how to close out your investigation?
• Understand that the cost of regulatory noncompliance remediation is significantly greater than the cost of compliance
• Leave the seminar with a better understanding of structured root cause analysis, effective investigational techniques and ensuring that the CAPA system is well established and maintained

Who will benefit:

This seminar will be of benefit to anyone working in a GMP regulated environment on global or domestic scale within the pharmaceutical and medical device industry. This includes quality, validation, engineering, manufacturing, and management personnel from sponsors and contract manufacturers (CMO) alike. This is anyone who wants to improve their ability to solve recurring problems should attend this training. Additionally, those who are actively involved in performing, overseeing, auditing, or managing investigations will find this course extremely beneficial.

• Quality Managers
• Auditors
• Operations and Manufacturing Personnel
• Validation
• Engineers
• Product/Process Development
• Principal Investigators, Site Research Directors and Coordinators
• Quality Assurance Staff
• Regulatory Managers and Professionals
• Compliance Managers and Professionals

Agenda:

Day 1 Schedule

Lecture 1:

Regulatory Expectations for Investigations

• Background and History
• FDA Regulations and Regulatory and Compliance Aspects
• Regulatory Expectations for Investigations
• FDA (21 CFR and Guidance Documents)
• EU references
• ICH
• FDA 483s and Warning Letters
• CAPA and RCA: root cause investigations follow steps such as identify the problem; evaluate its magnitude, which includes assessing risk; investigate and assign responsibility; and analyze and document the root cause of the problem.

Lecture 2:

What is RCA and Typical Problems

• Why most problem-solving models don’t get to the root cause, and a solution
• How analytical and creative thinking must be both separated and integrated
• Difference between content and process thinking

Lecture 3:

Investigation Process Overview

• Purpose, basics and sources (types and categories) of investigations
• Elements of a thorough investigation process (Discovery through
• Closeout)
• Classification levels
• Investigation planning, action items and documentation
• Company culture

Lecture 4:

Skills and Tools of an Effective Investigator

• Characteristics and techniques
• Reading and documentation practices
• Technical writing

Lecture 5:

(Re) Introduction to Root Cause Analysis (RCA)

• Principles of root cause analysis
• Why root cause analysis is difficult
• Methodology of root cause analysis

STEP 1 - Problem Definition

• How to ensure that the right problem is being worked on
• Tools and filters for priority setting
• Developing a clear and sufficient problem statement (includes practice)

STEP 2 - Understanding the Process

• How every problem is a process failure
• How diagrams can set boundaries and define interrelationships
• Using flowcharts to drill down into the right part of the process (includes practice)

STEP 3 - Identifying Possible Causes

• Multiple ways to identify possible causes
• Options for selecting or eliminating causes
• Logic trees as a cause and effect diagram and other tools for investigations

Lecture 6:

Defining the Deviation

• The problem statement
• Active listening and interviewing
• Process mapping
• Brainstorming tools
• "Is/Is Not" technique

FDA Enforcement Actions and Industry Trends 

Day 2 Schedule

Lecture 1:

Identifying Root Cause

• 5 Whys
• Relations Diagram
• Ishikawa diagrams (Fishbone)
• Fault Tree Analysis vs. Failure Modes and Effects Analyses (FMEA)
• Challenges

STEP 4 - Data Collection

• Population versus sampling; options for sampling
• Check sheets, graphs, and tables for discrete data collection
• Surveys, interviews, and field observation for opinions or less precise data

STEP 5 - Data Analysis

• Tools for discrete data analysis (run charts, histograms, pareto diagram, modified scatter diagram, pivot tables)
• Tools for softer type data (affinity diagram, relationship digraph)
• Integrative data analysis tools

Lecture 2:

Corrective and Preventive Actions (CAPA)

• What is the CAPA System
• Definition and regulatory interpretation
• Identifying and writing of corrective actions
• Abuses of the CAPA system
• Discuss robustness and effectiveness review

Lecture 3:

Management of the Investigation

• Members of the Investigation Team
• CAPA management/team

Lecture 4:

Members of the Investigation Team

• Culture
• Compliant document extensions and interim reports (justification)
• Management communication and notification
• Metrics and trending
• Interim controls, timetables and other reports
• Policy and Standard Operating Procedures
• Escalation action assessment
• Common barriers and solutions
• Investigator training

Lecture 5:

Consulting Case Study Practice - Incident/Events

• Participants role play consulting with instructor on a problem
• Review of key learning points

Lecture 6:

Case Study Practice

• Practice on a project relevant to participants’ organization

FDA Enforcement Actions and Trends

Lecture 7:

Interactive Exercises and Discussions

• Case studies
• Identification of noncompliance and questions to ask to determine the root cause
• Identification of necessary corrective actions and preventive actions

Questions and Summary 

Speaker

David R. Dills

Global Regulatory Affairs & Compliance Consultant and President, NovaQual 

David R. Dills, Global Regulatory Affairs & Compliance Consultant, Interim President, currently provides global regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III medical device, including combination products, In Vitro Diagnostics, nutraceuticals/supplements, cosmetics and biopharmaceutical manufacturers in multiple medical specialties and therapeutic areas on the global landscape, and has an accomplished record with more than 26 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA's, warning letters,483 observations, and customer generated compliance events, and prepares for and conducts QS and regulatoryaudits. He is currently acting and interim President at NovaQual LLC.

Location:  Philadelphia Date: May 16th & 17th, 2018 and Time: 9:00 AM to 5:00 PM

Venue:  WILL BE ANNOUNCED SOON

Price:

Price: $1,295.00 (Seminar Fee for One Delegate)

Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*

Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*

 Register now and save $200. (Early Bird)

Until April 20, Early Bird Price: $1,295.00 From April 21 to May 14, Regular Price: $1,495.00

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