Quality In Pharma Industry Analytical Method Validation

What you'll learn
Understand and define main principles of Analytical Method Validation by integrating Good Manufacturing Practices (GMP)
Define general scope of pharmaceutical analysis of drug substances and drug products in pharmaceutical industry
Understand and define main analytical method validation parameters required for analytical method validation
Discuss Analytical Method Validation process flow by integrating GMP rules
Understand basic elements of Analytical Method Validation Protocol and Analytical Method Validation Report
Requirements
Require mobile/tablet/laptop/personal computer with internet
To be student, graduate and/or chemistry/pharma professional
Description
Analytical methods must be developed and validated to ensure the quality of active pharmaceutical ingredients (APIs) and finished drug products for the intended use. Analytical method development and validation studies are required for marketing application and life cycle management of products. International Conference on Harmonization (ICH) and Food and Drug Administration (FDA) publish the documents/guidelines which clearly outline the requirements about analytical method development and validation. In this Analytical Method Validation course, pharmaceutical analysis methods, analytical method validation paramaters, GMP requirements about analytical method validation and analytical method validation process flow have been discussed.COURSE CONTENT1 INTRODUCTION 2 ANALYTICAL TEST METHODS IN PHARMACEUTICAL INDUSTRY 2_1 Introduction to Analytical Test Methods 2_2 Categories of Analytical Test Methods 3 ANALYTICAL TEST METHODS for DRUG SUBSTANCES 3_1 Description 3_2 Identification 3_3 Assay 3_4 Impurities 4 ANALYTICAL TEST METHODS for DRUG PRODUCTS 4_1 Description 4_2 Identification 4_3 Assay & Content Uniformity 4_4 Impurities 5 ICH GUIDELINE SCOPE for ANALYTICAL TEST METHOD 6 INTRODUCTION TO ANALYTICAL METHOD VALIDATION 6_1 Types of Analytical Methods to be Validated 6_2 Analytical Method Validation Parameters 6_3 Definitions for Analytical Method Validation 7 ANALYTICAL METHOD VALIDATION PARAMETERS 7_1 Specificity 7_2 Accuracy 7_3 Precision 7_4 Precision & Repeatability 7_5 Precision & Intermediate Precision 7_6 Precision & Reproducibility 7_7 Summary for Precision 7_8 Detection Limit & Quantitation Limit 7_9 Linearity & Range 7_10 Robustness 8 ANALYTICAL METHOD VALIDATION STEPS 9 CONCLUSION
Overview
Section 1: INTRODUCTION
Lecture 1 Introduction
Section 2: ANALYTICAL TEST METHODS IN PHARMACEUTICAL INDUSTRY
Lecture 2 Introduction to Analytical Test Methods
Lecture 3 Categories of Analytical Test Methods
Section 3: ANALYTICAL TEST METHODS for DRUG SUBSTANCES
Lecture 4 Description
Lecture 5 Identification
Lecture 6 Assay
Lecture 7 Impurities
Section 4: ANALYTICAL TEST METHODS for DRUG PRODUCTS
Lecture 8 Description
Lecture 9 Identification
Lecture 10 Assay & Content Uniformity
Lecture 11 Impurities
Section 5: ICH GUIDELINE SCOPE for ANALYTICAL TEST METHOD
Lecture 12 ICH Guideline Scope for Analytical Test Method
Section 6: INTRODUCTION TO ANALYTICAL METHOD VALIDATION
Lecture 13 Types of Analytical Methods to be Validated
Lecture 14 Analytical Method Validation Parameters
Section 7: ANALYTICAL METHOD VALIDATION PARAMETERS - SPECIFICITY
Lecture 15 Specificity-1
Lecture 16 Specificity-2
Section 8: ANALYTICAL METHOD VALIDATION PARAMETERS-ACCURACY
Lecture 17 Accuracy-1
Lecture 18 Accuracy-2
Lecture 19 Accuracy-3
Section 9: ANALYTICAL METHOD VALIDATION PARAMETERS-PRECISION
Lecture 20 Precision
Lecture 21 Precision & Repeatability
Lecture 22 Precision & Intermediate Precision
Lecture 23 Precision & Reproducibility
Lecture 24 Summary for Precision, Repeatability, Intermediate Precision and Reproducibility
Section 10: ANALYTICAL METHOD VALIDATION PARAMETERS - DEDECTION LIMIT & QUANTITION LIMIT
Lecture 25 Detection Limit & Quantitation Limit
Section 11: ANALYTICAL METHOD VALIDATION PARAMETERS - LINEARITY & RANGE
Lecture 26 Linearity & Range
Section 12: ANALYTICAL METHOD VALIDATION PARAMETERS - ROBUSTNESS
Lecture 27 Robustness
Section 13: ANALYTICAL METHOD VALIDATION STEPS
Lecture 28 Analytical Method Validation Steps
Section 14: CONCLUSION
Lecture 29 Conclusion
Anyone who is looking to learn Analytical Method Validation (AMV),Anyone who wants to learn the requirements / parameters of Analytical Method Validation (AMV),Anyone who wants to be qualified for analytical chemistry, instrumental analysis and pharmaceutical industry


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