What you'll learn

Assay Method validation
Preparation of protocol
Preparation of report
Conducting calculations

Course content

6 sections • 24 lectures • 4h 45m total length

INTRODUCTION4:42
Introduction: The content of assay method validation mastery course is explained here

ASSAY METHOD VALIDATION PROTOCOL PREPARATION: SYSTEM SUITABILITY AND SPECIFICITY47:56
This video will walk you through on how system suitability and specificity parameter can be described in assay method validation protocol
ASSAY METHOD VALIDATION PROTOCOL PREPARATION: PRECISION7:29
This video will walk you through on how precision can be described in assay method validation protocol
ASSAY METHOD VALIDATION PROTOCOL PREPARATION: LINEARITY6:29
This video will walk you through on how linearity can be described in assay method validation protocol
ASSAY METHOD VALIDATION PROTOCOL PREPARATION: ACCURACY9:08
This video will walk you through on how Accuracy can be described in assay method validation protocol
ASSAY METHOD VALIDATION PROTOCOL PREPARATION: RANGE3:09
This video will walk you through on how range can be described in assay method validation protocol
ASSAY METHOD VALIDATION PROTOCOL PREPARATION: ROBUSTNESS21:26
This video will walk you through on how robustness parameter can be described in assay method validation protocol

CALCULATION OF RESULT FOR SYSTEM SUITABILITY AND SPECIFICITY11:46
This video will walk you through on how calculation for system suitability and specificity parameter can be performed using automated calculation sheet in case of assay method validation
CALCULATION OF RESULT FOR PRECISION12:58
This video will walk you through on how calculation for precision parameter can be performed using automated calculation sheet in case of assay method validation
CALCULATION OF RESULT FOR LINEARITY7:50
This video will walk you through on how calculation for linearity parameter can be performed using automated calculation sheet in case of assay method validation
CALCULATION OF RESULT FOR ACCURACY12:54
This video will walk you through on how calculation for accuracy parameter can be performed using automated calculation sheet in case of assay method validation
CALCULATION OF RESULT FOR ROBUSTNESS10:13
This video will walk you through on how calculation for robustness parameter can be performed using automated calculation sheet in case of assay method validation

ASSAY METHOD VALIDATION REPORT PREPARATION: SYSTEM SUITABILITY AND SPECIFICITY43:08
This video will walk you through on how the results of system suitability and specificity parameter can be reported in a method validation report for assay by HPLC
ASSAY METHOD VALIDATION REPORT PREPARATION: PRECISION9:35
This video will walk you through on how the results of precision parameter can be reported in a method validation report for assay by HPLC
ASSAY METHOD VALIDATION REPORT PREPARATION: LINEARITY3:43
This video will walk you through on how the results of linearity parameter can be reported in a method validation report for assay by HPLC
ASSAY METHOD VALIDATION REPORT PREPARATION: ACCURACY6:55
This video will walk you through on how the results of accuracy parameter can be reported in a method validation report for assay by HPLC
ASSAY METHOD VALIDATION REPORT PREPARATION: RANGE6:10
This video will walk you through on how the results of range can be reported in a method validation report for assay by HPLC
ASSAY METHOD VALIDATION REPORT PREPARATION: ROBUSTNESS35:59
This video will walk you through on how the results of robustness parameter can be reported in a method validation report for assay by HPLC

TEMPLATE FOR CONCENTRATION MATRIX PREPARATION FOR ASSAY METHOD VALIDATION0:03
The attached automated calculation sheet will help you in designing concentration matrix during assay method validation protocol preparation
TEMPLATE FOR ASSAY METHOD VALIDATION PROTOCOL0:03
This generic template will help users to prepare protocol for assay method validation
TEMPLATE FOR CALCULATION OF RESULTS FOR ASSAY METHOD VALIDATION0:04
This automated calculation sheet will help users during calculation of results for various parameters pertaining to assay method validation
TEMPLATE FOR ASSAY METHOD VALIDATION REPORT0:04
This template will help users to prepare report for assay method validation
TUTORIALS0:01
Tutorial will help to understand concept to deeper level

Requirements

Basic knowledge of Analytical chemistry

Description

I am very glad to launch this course!

This course will help you understanding ins and outs about assay method validation for HPLC methods. I have created this course with live demonstration for easy understanding. You will find me executing all activities here in the course.

This course will make you MASTER in preparation of concentration matrix for various assay method validation parameters. It will guide you in preparation of protocol as well as report. You will also find information on how to calculate end results for each validation parameter.

On top of everything, you will get downloadable versions of required templates and formats

Who this course is for:

Quality control, Quality assurance, Analytical R&D,
BPharm, MPharm, BSc, MSc, Pharmaceutical Industry, chemical industry, food industry

What you'll learn

Explore related topics

Course content

INTRODUCTION1 lecture • 5min

CONCENTRATION MATRIX PREPARATION: ASSAY METHOD VALIDATION BY HPLC1 lecture • 24min

PREPARATION OF PROTOCOL FOR ASSAY METHOD VALIDATION BY HPLC6 lectures • 1hr 36min

CALCULATION OF RESULTS FOR ASSAY METHOD VALIDATION BY HPLC5 lectures • 56min

PREPARATION OF REPORT FOR ASSAY METHOD VALIDATION BY HPLC6 lectures • 1hr 46min

TEMPLATES AND FORMATS5 lectures • 1min

Requirements

Description

Who this course is for: