This series of courses covers the application of statistical tools commonly used in the medical devices and pharmaceutical industries. Learn to use data analysis techniques to understand variation and defects, determine the useful life of a product, assess if a process is capable of meeting customer specifications, and monitor the stability of a validated process. Learn to use Minitab tools for validation of analytical methods, determine product stability and shelf-life, estimate product reliability, determine reliability demonstration test plans, accelerated life testing etc.

Introduction

According to FDA’s CFR 820.250, “Where appropriate, each manufacturer shall establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics.”

This series of courses covers the application of statistical tools commonly used in the medical devices and pharmaceutical industries. Learn to use data analysis techniques to understand variation and defects, determine the useful life of a product, assess if a process is capable of meeting customer specifications, and monitor the stability of a validated process. Learn to use Minitab tools for validation of analytical methods, determine product stability and shelf-life, predict when your product will fail etc.

Module 1 introduces the Minitab environment and important statistical concepts, while Module 2 focuses on application of statistics as a tool for assessing process capability, measurement system capability, product stability, acceptance sampling, regression etc.

Course Outline

There are two modules in this series and each module is of three days’ duration. Below is a course outline for each module.

Module 1: Basic Statistics with Minitab

Pre-requisite: Leaving Cert Maths, Undergraduate Introductory Statistics or an interest in the subject.

During: 3 days

Venue: Virtual Delivery

Course Fee: €895

Day 1

The Minitab Environment

• Get to know Minitab

Statistical Concepts

• Understand key statistical concepts including central tendency, measures of dispersion, descriptive statistics, inferential statistics, Central Limit Theorem etc.
• Learn how to present your data numerically and graphically with Minitab – histograms, boxplots, scatterplots, Run chart, cumulative and normal probability plots.
• Understand fundamentals of probability theory.
• Understand the distribution of your data
• • Continuous distributions – normal, t distributions etc.
  • Discrete distributions – binomial, Poisson etc.
  • Use probability distributions to predict your process behaviour.

Day 2

Statistical Decision Making

• Parameter estimation – point estimate, confidences intervals, tolerance intervals for a given coverage and confidence level, k factor etc.
  • Use tolerance interval to quantify the reliability of your products.
  • Use tolerance interval as acceptance criteria for process validation.
• Understand how to use Minitab to make statistical decisions based on calculated risks – t-tests, F-test, Chi-sq test, Goodness-of-fit, analysis of variance (ANOVA), paired t-test, test for outliers – Grubb’s test and Dixon’s tests.
• Understand the relationship between p-value and test statistic, eg Anderson Darling.
• Understand the relationship between power and sample size for decision making. Use Minitab to calculate an optimum sample size for confidence interval and tolerance interval.

Day 3

Statistical Process Control

• Understand the concepts of process variation and how to monitor and control your process.
• Learn the difference between control charts for attributes and variables.
• Learn how to choose an appropriate control chart for your process.
• Learn how to use Minitab to construct and plot the various control charts – IMR, Xbar-R, Xbar-S, p, np, C and U charts.

Terms and Conditions

Cancellation Policy

Events Cancellation Policy: Cancellations will be accepted up to 72hrs before each event. Events which are cancelled within 72 hours of scheduled date shall incur a cancellation fee equal to 50% of the agreed cost. Registrants who fail to attend the event will be charged 100% of the full fee. This policy applies to all events.

Training Cancellation Policy

Registrants who cancel over 2 UNITs in advance of scheduled training date shall incur no cancellation fee. Registrants who cancel within 2 UNITs of scheduled training date shall incur a cancellation fee equal to 50% of the cost. Registrants who give less than 24 hours’ notice or fail to attend training will be charged 100% of the full fee.

Please quote Purchase Order number if required on invoice.

Irish Laws

These Terms & Conditions are governed by Irish Law. Place of Litigation is the Republic of Ireland. These conditions shall be governed and construed in accordance with the laws of Ireland, and the customer submits to the exclusive jurisdiction of the Irish Laws.