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QA/RA Consulting, Auditing & Training

Root Cause Analysis for Combination Products and Drug Delivery Systems

Learn fundamental problem-solving tools and tactics and how to apply them through exercises and other activities. Root cause analysis (RCA) is the essential investigation method used by life science professionals to understand failures throughout a combination product’s life cycle. Students will master the entire root cause analysis process, from accurately identifying and defining a combination product problem to designing an effective intervention. This practical course goes beyond theory to teach specific steps and tools so students can immediately apply what they learn. Students are encouraged to bring current or recent problems from their own organization to use in the application of the tools.

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Brief Overview of This Root Cause Analysis Class

SkillsLab Class ?

Class Content

In-Depth

Class Duration

5 Half-Days

Teaching Format

Live, Instructor-Led

Delivery Options

Private Team Training Only*

Certification of Completion

Yes

Continuing Education Units (CEU)

2.4

* This class is only available privately to groups of six or more. We can deliver the training at your facility or virtually, Ask for details.

Upcoming Classes

Upcoming Root Cause Analysis for Combo Products Training Classes

SkillsLab $3295

SkillsLab $3295

There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!

GROUP DISCOUNT

Save up to

25%

Register 3 people, 4th attends free!

Free

*This offer cannot be combined with any other promotional offer(s).

Course Overview

Here's What We Cover in This Class on Root Cause Analysis for Combination Products and Drug Delivery Systems

This course provides your organization with problem-solving tools and knowledge of how to apply them in order to understand failures throughout a combination product’s life cycle, including out-of-specification elements.

Course Overview

SkillsLab Class

Defining Combination Products

Combination product terminology, definitions, and examples
Primary mode of action (PMOA)
Manufacturing scenarios
Regulatory overview of combination products: US FDA and EU

Exercise! Identifying Combination Products

Introduction to Nonconformances

Types of nonconformances and examples
Types of errors
Impacts of departures from established procedures and requirements
Regulatory requirements and standards for investigating errors, including US FDA and ICH

Exercise! Identify a Nonconformance

Out-of-Specification

Out-of-specification (OOS) definition and examples
Laboratory investigations vs. full-scale OOS investigations
Final report and postmarket reporting

Exercise! Warning Letter

Define the Problem

Root cause analysis
A problem-solving culture
Creating problem statements
Common problem definition tools

Exercise! Problem Definition

Refine the Problem

Diagnosing the problem
The problem specification
Data collection and stratification

Exercise! Refining the Problem

Analyze the Root Cause

Root cause investigation process
Root cause investigation tools: Fishbone and 5 Whys
Fault tree analysis (FTA)
Contradiction matrix tool

Exercise! Apply the 5 Whys Tool

Exercise! Apply the Fishbone Tool

Verify the Root Cause

Root cause verification
Testing and verification activities, including logic, trials, and hypothesis testing

Exercise! Verify the Root Cause

Implement the Remedy

Root cause analysis and CAPA
Solve the problem
Effectiveness verification

Exercise! Create, Select, and Implement Solutions

Exercise! Effectiveness Verification

Defend the Investigation

FDA expectations of investigations
Common CAPA issues
Preparing for inspections and audits

What You Will Learn

At the conclusion of this training class, you will be able to

SkillsLab

Identify regulatory requirements and standards for root cause analysis applicable to combination products including US FDA, ICH, and the EU Medical Device Regulation

Describe the benefits of creating a problem-solving culture within the organization

Describe nonconformances / deviations

List the events of out-of-specification (OOS) investigations

Apply root cause analysis tools to determine root causes of failures

Create an effective problem statement

Analyze and verify root cause

Implement remedies to problems

Document corrective and preventive action (CAPA) findings

Defend the investigation

Prepare for an FDA inspection of CAPA

Who Should Attend

Anyone from the medical device, biotech, and pharmaceutical industries participating in root cause analysis investigations will benefit from this training. Recommended for staff or top management in such areas as quality engineering, QA/QC, manufacturing operations, CAPA management, and research and development.

Quality engineers
QA/QC personnel
Manufacturing ops personnel
CAPA managers
R&D personnel

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