Quality in Pharma Industry : Analytical Method Validation

Quality in Pharma Industry : Analytical Method Validation, available at $59.99, has an average rating of 4.25, with 29 lectures, based on 47 reviews, and has 207 subscribers.

You will learn about 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 This course is ideal for individuals who are Anyone who is looking to learn Analytical Method Validation (AMV) or Anyone who wants to learn the requirements / parameters of Analytical Method Validation (AMV) or Anyone who wants to be qualified for analytical chemistry, instrumental analysis and pharmaceutical industry It is particularly useful for Anyone who is looking to learn Analytical Method Validation (AMV) or Anyone who wants to learn the requirements / parameters of Analytical Method Validation (AMV) or Anyone who wants to be qualified for analytical chemistry, instrumental analysis and pharmaceutical industry.

Enroll now: Quality in Pharma Industry : Analytical Method Validation

Summary

Title: Quality in Pharma Industry : Analytical Method Validation

Price: $59.99

Average Rating: 4.25

Number of Lectures: 29

Number of Published Lectures: 29

Number of Curriculum Items: 29

Number of Published Curriculum Objects: 29

Original Price: $19.99

Quality Status: approved

Status: Live

What You Will 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

Who Should Attend

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

Target Audiences

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

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 studiesare 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 Validationcourse, pharmaceutical analysis methods, analytical method validation paramaters, GMP requirements about analytical method validation and analytical method validation process flow have been discussed.

COURSE CONTENT

1 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

Course Curriculum

Chapter 1: INTRODUCTION

Lecture 1: Introduction

Chapter 2: ANALYTICAL TEST METHODS IN PHARMACEUTICAL INDUSTRY

Lecture 1: Introduction to Analytical Test Methods

Lecture 2: Categories of Analytical Test Methods

Chapter 3: ANALYTICAL TEST METHODS for DRUG SUBSTANCES

Lecture 1: Description

Lecture 2: Identification

Lecture 3: Assay

Lecture 4: Impurities

Chapter 4: ANALYTICAL TEST METHODS for DRUG PRODUCTS

Lecture 1: Description

Lecture 2: Identification

Lecture 3: Assay & Content Uniformity

Lecture 4: Impurities

Chapter 5: ICH GUIDELINE SCOPE for ANALYTICAL TEST METHOD

Lecture 1: ICH Guideline Scope for Analytical Test Method

Chapter 6: INTRODUCTION TO ANALYTICAL METHOD VALIDATION

Lecture 1: Types of Analytical Methods to be Validated

Lecture 2: Analytical Method Validation Parameters

Chapter 7: ANALYTICAL METHOD VALIDATION PARAMETERS – SPECIFICITY

Lecture 1: Specificity-1

Lecture 2: Specificity-2

Chapter 8: ANALYTICAL METHOD VALIDATION PARAMETERS-ACCURACY

Lecture 1: Accuracy-1

Lecture 2: Accuracy-2

Lecture 3: Accuracy-3

Chapter 9: ANALYTICAL METHOD VALIDATION PARAMETERS-PRECISION

Lecture 1: Precision

Lecture 2: Precision & Repeatability

Lecture 3: Precision & Intermediate Precision

Lecture 4: Precision & Reproducibility

Lecture 5: Summary for Precision, Repeatability, Intermediate Precision and Reproducibility

Chapter 10: ANALYTICAL METHOD VALIDATION PARAMETERS – DEDECTION LIMIT & QUANTITION LIMIT

Lecture 1: Detection Limit & Quantitation Limit

Chapter 11: ANALYTICAL METHOD VALIDATION PARAMETERS – LINEARITY & RANGE

Lecture 1: Linearity & Range

Chapter 12: ANALYTICAL METHOD VALIDATION PARAMETERS – ROBUSTNESS

Lecture 1: Robustness

Chapter 13: ANALYTICAL METHOD VALIDATION STEPS

Lecture 1: Analytical Method Validation Steps

Chapter 14: CONCLUSION

Lecture 1: Conclusion

Instructors

Aydan Ozden
R&D Formulation Development Executive

Rating Distribution

1 stars: 0 votes
2 stars: 1 votes
3 stars: 6 votes
4 stars: 24 votes
5 stars: 16 votes

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