Statistical Evaluation of Stability Study according to ICH

Description

If you are a pharma professional searching for statistical knowledge to use it in your daily life, if you want to learn basic statistics, learn how to evaluate stability data, how to conduct hypothesis testing and more, this course is what you are looking for. You will get exact amount of statistical knowledge which you need in your daily work for stability study.

Design of this course in fully compliant with ICH and detailed overview of guidelines will be done at the end of this course.

After completing first part of this course you will learn:

• Data Types (Continuous and Attribute)

• Types of Statistics (Descriptive and Inferential)

• Hypothesis Testing (p-value, t-test, f-test, ANOVA, ANCOVA)

• Regression (Fitted Line, r, R-sq, residual, error)

• Distribution (Histogram, Central Limit Theorem, Normality)

• Poolability (CICS, SICS and SISS)

• Confidence and Prediction Intervals

• Treatment Factors (Fixed Factor and Random Factor)

• Interaction Effect and Variation Effect

• OOS/OOT/OOE (Definition and Treatment)

• Special Cause and Common Cause

This is the basic knowledge that you need to start your statistical journey.

After understanding these concepts, we will go to real examples, and you will learn:

• Shelf-life Determination

• Internal Release Limit Calculation

• Interpreting Minitab Results

• Roadmap for Hypothesis Testing

• Possible Industry Problems and Their Solutions

• Case Studies

• Minitab Extras

• Industry Tips

Knowledge you gained in course will help you not only for stability study, but also for a lot of different applications done in GMP environment each day.

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