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Root Cause Analysis for Better Investigations

Purpose

To conduct or facilitate an individual or team-based investigation that solves problems and gets results, and complies with FDA expectations in the pharmaceutical and biotech industries.

Objectives

1. Use tools and techniques to effectively identify the deviation statement.

2. Identify the root cause of the deviation.

3. Generate and objectively select the best corrective and preventive actions.

4. Assess the risk of implementing the corrective action and preventive action.

5. Develop a contingency plan to preventive action implementation.

6. Create corrective actions and preventive action metrics.

About the Class

1. This class uses current deviations to practice the techniques taught.

2. The optional final exam is approximately 25 questions.

3. Each student receives a student guide containing a representation of the program’s

slides and graphics with space provided for note taking.

4. This class can accommodate up to 25 people.

5. Duration: 8 hours.

Course Topics

CGMPs and Investigations

The CGMPs and investigations

Investigation citation issues

Deviation Statement

Defining the problem

Tool: 5-Why’s

Class Project: Work on a real plant example with instructor coaching

Deviation Investigation

Deviation investigation defined

Tool: Distinctions

Tool: Walk-Through-Analysis

Tool: Change Analysis

Tool: Control Barrier Gap Analysis

Research assignments

Class Project: Work on a real plant example with instructor coaching

Root Cause Analysis

Root Cause defined

Root Cause types

Path forward

Tool: Root Cause Analysis Diagram

Prioritizing root causes

Identifying the most likely root cause

Class Project: Work on a real plant example with instructor coaching

Corrective Actions

Corrective Action defined

Tool: Brainstorming

Solution identification

Corrective action generation tools and techniques

Class Project: Work on a real plant example with instructor coaching

Preventive Actions

Preventive Action defined

Tool: Control Barrier Needs Analysis

Class Project: Work on a real plant example with instructor coaching

Risk Analysis

What is acceptable risk?

Tool: Simple Risk Assessment

Go/no-go decisions

Tool: Failure Mode and Effects Analysis

Prioritizing FMEA results

Managing the risks of a corrective and preventive action

Class Project: Work on a real plant example with instructor coaching

Metrics

Measuring corrective action and preventive action success

Assuring follow-up success

Setting follow limits

Summary

Review of tools used in class

Optional on line exam

Call to learn about how we can customize this outline for any of your site's CGMP training needs. Standard outlines may change without notice. To speak with the lead instructor for this class please call Allan Dewes at 415.487.3500.

For a prompt reply to requests and questions: 415.487.3500 | allan.dewes@skillsplusinc.com | Fax: 415.487.1926

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