Reliability Analysis
Biotech, Pharmaceutical and Medical Device
This course is specifically designed to met the analytical needs of those individuals working within FDA regulated industries. Areas of focus are distribution analysis, area under the curve estimation, hypothesis testing, life and survival estimation, thermal sensitivity, confidence intervals and multiple factor modeling. The course requires 8 hours of instruction.

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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
ESDA is a recommended course prior to taking LTRA.
Course Objectives
  1. Determine product reliability performance.
  2. Understand and apply non-parametric reliability analysis.
  3. Understand and apply parametric reliability analysis.
  4. Perform multivariate reliability assessment.
  5. Understand and apply recurrence analysis.
  6. Use Arrhenius transformations in reliability modeling.
  7. Select appropriate sample sizes for MTBF studies.
  8. Model reliability improvement using reliability growth models.
Detailed Course Outline
Introduction to reliability analysis and basic statistics
Nonparametric reliability analysis (Kaplan-Meier)
Parametric reliability analysis (LogNormal, Exponential, Weibull)
Competing Causes
Lifetime distribution analysis
Fit Life by X
Multivariate reliability analysis (Parametric Survival)
Recurrence analysis
MTBF analysis
Reliability growth analysis
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