What you'll learn
Data Types (Continuous and Attribute)
Types of Statistics (Descriptive and Inferential)
Regression (Fitted Line, r, R-sr, 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
Shelf-life Determination
Internal Release Limit Calculation
Interpreting Minitab Results
Roadmap for Hypothesis Testing
Possilble Industry Problems and Their Solutions
Requirements
Any statistical backround required.
Basic knowledge of Stability Study in Pharmaceutical Industry.
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 IntervalsTreatment Factors (Fixed Factor and Random Factor)Interaction Effect and Variation EffectOOS/OOT/OOE (Definition and Treatment)Special Cause and Common CauseThis 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 DeterminationInternal Release Limit CalculationInterpreting Minitab ResultsRoadmap for Hypothesis TestingPossible Industry Problems and Their SolutionsCase StudiesMinitab ExtrasIndustry TipsKnowledge 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.
Overview
Section 1: Introduction and General Information
Lecture 1 Introduction
Lecture 2 References
Lecture 3 Statistical Software for Stability Study
Lecture 4 Before Starting
Section 2: Basic Concepts
Lecture 5 Types of Statistics
Lecture 6 Origins of Variation
Lecture 7 Variation Effect in Stability Study
Lecture 8 Resgression and Fitted Line
Lecture 9 r and R-sq
Lecture 10 Residuals
Lecture 11 Regression in Minitab
Section 3: Hypothesis Testing
Lecture 12 Definition
Lecture 13 Alpha level and p-value
Lecture 14 Stages of Hypothesis Testing
Lecture 15 Types of Data
Lecture 16 Distribution
Lecture 17 Distribution in Minitab
Lecture 18 Normality
Lecture 19 Normality in Minitab
Lecture 20 Central Limit Theorem
Lecture 21 CLT in Minitab
Section 4: Types of Hypothesis Testing
Lecture 22 Roadmap for Hypothesis Testing
Lecture 23 t-test in Minitab
Lecture 24 f-test in Minitab
Lecture 25 One-way ANOVA in Minitab
Section 5: Statistical Terms for Stability Study
Lecture 26 Confidence Interval (CI)
Lecture 27 Prediction Interval (PI)
Lecture 28 Out-of-specification (OOS)
Lecture 29 Out-of-trend (OOT)
Lecture 30 Out-of-expectation (OOE)
Lecture 31 Interaction Effect
Lecture 32 Treatment Factors: Fixed Factor and Random Factor
Lecture 33 Data Collection for Statistical Evaluation of Stability Study
Lecture 34 Poolability
Lecture 35 Internal Release Limit (IRL)
Lecture 36 Internal Release Limit - Case Study
Section 6: Case Studies in Minitab
Lecture 37 Case-1 (Common Intercept Common Slope)
Lecture 38 Case-2 (Seperate Intercept Common Slope)
Lecture 39 Case-3 (Seperate Intercept Seperate Slope)
Lecture 40 Case-4 (Treatment with Random Factors)
Section 7: ICH Guidelines Overview
Lecture 41 ICH Q1A - Stability Testing of New Drug Substances and Products
Lecture 42 ICH Q1E - Evaluation for Stability Data
Section 8: Notes and Conclusion
Lecture 43 Notes and Tips
Lecture 44 Conclusion
Section 9: Final Quiz
Manufacturing Science and Technology Professionals,Research and Development Professionals,Quality Professionals,Pharma Professionals,Pharmacy Graduate Students


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