Module 2: GBI Advanced Statistics with Minitab

Pre-requisite: Module 1 or Minimum of 70% score in Basic Statistics Pre-course Test

During: 3 days

Venue: Virtual Delivery

Course Fee: €890

Day 1

Review of Key Statistical Tools

• Review of central tendency and dispersion – relating range to standard deviation.
• Review of standard normal distribution – use of z-value to calculate out-of-tolerance work.
• Review of control charts for variables – IMR, Xbar-R charts.

Process Capability Analysis

• Understand the assumptions of process capability.
• Understand capability metrics – Cp, Cpk, Pp, Ppk and Cpm, Z-Bench, etc.
• Use of capability as acceptance criteria for process validation.
• Learn how to use Minitab’s Capability Sixpack to assess assumption of normality.
• Learn how to use Minitab’s Individual Distribution Identification tool to find a distribution which best describes your data.
• Learn how to analyse the capability of a stable process.
• Learn how to analyse capability of a non-normal process.

Correlation and Regression Analysis

• Understand the difference between regression and correlation.
• Appreciate data considerations for regression analysis.
• Learn when and how to use Minitab’s “Fitted Line Plot”, “Fit Regression Model” and “Nonlinear Regression” tools.
• Analyse regression output from Minitab – coefficients, R-squared, residuals, ANOVA summary of regression statistics etc
• Understand how Minitab calculates correlation coefficient, R-squared etc 
• Learn how to use the regression model to make predictions – understand importance of residuals etc.
• Learn how to use regression as a method validation tool
  • Learn how to relate slope and intercept to limit of detection (LOD) and limit of quantification (LOQ) when conducting method validation.

Day 2

Test Method Validation (Medical Devices)

• Regulatory requirements – FDA 21CFR820
• Test Method Validation (TMV) data type – variable vs attribute
• TMV terminology – accuracy, precision, stability, linearity, repeatability, reproducibility.
• TMV process – prerequisite, test specifics and protocols
• TMV Acceptability criteria – Measurement Systems Analysis (MSA)
• MSA metrics – Precision-to-Total ratio, Precision-to-Tolerance ratio etc
• Measurement Systems Analysis concepts. 
  • Type 1 Gage study,
  • Gage Linearity study and
  • Gage R & R (Crossed).
• Attribute Agreement Analysis – Kappa and Kendall indices

Validation of Analytical Procedures (Pharmaceuticals)

• Regulatory requirements – ICH Q2(R1)
• Parameters to be checked for method validation – specificity, accuracy, precision, stability, range, linearity, LOD, LOQ, RSD, repeatability, reproducibility.
• Understand how to calculate these parameters.

Day 3

Acceptance Sampling

• Regulatory reminder for medical devices – 21CFR 820.250
• Review of sampling methods.
• Overview of binomial and hypergeometric distributions and their relevance to acceptance sampling.
• Acceptance Sampling concepts – single, multiple, sequential etc.
• Consideration of Risk/harm to user – critical, major, minor etc.
• Acceptance sampling indices – AQL, RQL, LTPD/RQL, AOQL.
• Learn how to use Minitab to define a ‘Zero Failure” sampling plan.
• Learn how to use Minitab to derive an attribute sampling plan.

Stability and Shelf Life Analysis

• Regulatory requirements – ICH, FDA etc.
• Understand the difference between real-time and accelerated stability testing – Q-Rule, Arrhenius, power models etc.
• Understand the use of life-time distributions in shelf-life determination – Weibull, lognormal, exponential etc.
• Learn how to use Minitab’s ‘Stability Study’ to estimate shelf-life based on real-time test data.
• Learn how to use Minitab’s ‘Reliability/Survival’ tool to estimate shelf-life based on accelerated testing data.

Introduction to Medical Device Reliability

• Estimate device reliability with parametric distribution analysis.

• Device acceleration life testing.

• Device demonstration Test Plans.

• Warranty Analysis etc.

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.

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