Quality Risk Management and FMEA
Biotech, Pharmaceutical and Medical Device
This course is specifically designed to meet the analytical needs of those individuals working within FDA regulated industries. Areas of instruction covers the topics associated with risk management including risk management definitions, risk management process and risk assessment tools including Failure Modes and Effects Analysis. The course requires 16 hours of instruction.

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Download the full curriculum for Statistical and Analytical courses in PDF format.

Biotech, Pharmaceutical & Medical Device Courses

Systematic product development, Quality by Design courses, consulting services and analytical training for biotechnology, pharmaceutical and medical device industries. QbD provides guidance to facilitate design of products and processes that maximize the product’s efficacy and safety profile while enhancing product manufacturability and control.

Lean Six Sigma

Complete curriculum for new product development, manufacturing and business process performance optimization.

Tools & Templates

Development tools and templates created by Thomas A. Little Consulting have been used by numerous companies to aid and support various aspects of product development, problem solving, data analysis and risk assessment.

Attendees
This course is required for all scientists, engineers and quality professionals who actively work on all aspects of discovery, product and process development where the goal is to characterize, optimize and improve product and process performance.
Prerequisites
There are no prerequisites for this course.
Course Objectives
  1. Understand the definitions, process and tools associated with Quality Risk Management
  2. Identify potential design, process or test issues associated with product and performance risk
  3. Understand the tools and methods for risk assessment and prioritization
  4. Understand the various types of FMEAs
  5. Apply the basic steps for FMEA generation
  6. Know when and how to apply FMEA to product and process development
  7. Prioritize and manage risk reduction opportunities from FMEA results
Detailed Course Outline
Section I: Quality Risk Management Principles and Process
Risk management principles
Risk management process
Responsibilities
Risk assessment
Risk control
Risk communication
Risk review
Section II: Risk Analysis Tools
Basic quality tools and risk weighted analysis
Cause and effect diagrams
Process flow and risk assessment
Pareto and Risk Weighted Pareto analysis
Histograms, capability, simulation and Margin
Control charts
Regression
DOE (product and process) and MSA
Section III: Technical Risk Assessment and Failure Modes and Effects Analysis
Application areas for FMEA
FMEA preparation
FMEA generation workshop
Section IV: Methods for Reducing Risk
FMEA action plans and risk reduction
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