Training Course
Syllabus:
**Course Description**
Throughout 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries, the application of statistical methods are specified for: performing measurement systems analysis (MSA), using design of experiment (DOE) for process development and validation, developing process control charts, and determining process capability indices. Different statistical methods are required for each of these particular applications. Data and tolerance intervals are common tools used for setting acceptance criteria and specifications. Simple linear regression and analysis-of-covariance (ANCOVA) are used for setting expiries and conducting stability analysis studies. Two-sample hypothesis tests, analysis-of-variance (ANOVA), regression, and ANCOVA are methods used for analyzing designed experiment for process development and validation studies. Descriptive statistics (distribution, summary statistics), run charts, and probability (distributions) are used for developing process control charts and developing process capability indices. This course provides instruction on how to apply the appropriate statistical approaches: descriptive statistics, data intervals, hypothesis testing, ANOVA, regression, ANCOVA, and model building. Once competence in each of these areas is established, select industry-specific applications are presented for the participants: MSA, DOE, SPC, and process capability. **Learning Objectives:**
Upon completing this course participants should be able to: describe and analyze a distribution of data develop summary statistics generate and analyze statistical intervals and hypothesis tests to make data-driven decisions describe the relationship between and among two or more factors or responses understand issues related to sampling and calculate appropriate sample sizes use statistical intervals: confidence, prediction, and tolerance understand how Measurement Systems Analysis (MSA) can be to estimate variance associated with: repeatability, intermediate precision, and reproducibility understand how design of experiments (DOE) is used in process development understand what it means for a process to be in (statistical) control and capable **DAY 01(8:30 AM - 4:30 PM)**
08.30 AM - 09.00 AM: Registration 09.00 AM: Session Start Basic Statistics sample versus population descriptive statistics describing a distribution of values Intervals confidence intervals prediction intervals tolerance intervals Hypothesis Testing introducing hypothesis testing performing means tests performing normality tests ANOVA defining analysis of variance and other terminology discussing assumptions and interpretation interpreting hypothesis statements for ANOVA performing one-way ANOVA **DAY 02(8:30 AM - 4:30 PM)**
Regression producing scatterplots and performing correlation performing simple linear regression Model Building introduction performing N-way ANOVA performing multiple linear regression performing ANCOVA Applied Statistics introduction to Measurement Systems Analysis (MSA) introduction to design of experiments (DOE) introduction to process control and capability |

Seminar Summary:
This course provides instruction on how to apply the appropriate statistical approaches: descriptive statistics, data intervals, hypothesis testing, ANOVA, regression, ANCOVA, and model building. (see
full course description) |