Good Laboratory Practices - Edu Lowcostlivin

Course Feature

Cost

Paid
Provider

Udemy
Certificate

Paid Certification
Language

English
Start Date

2021-08-29
Learners

No Information
Duration

No Information
Instructor

Hitendrakumar Shah

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4.5

176 Ratings

This course on Good Laboratory Practices will provide a comprehensive overview of data integrity in analytical and microbiology laboratories, as well as analytical method validations, stability studies, and human error investigations. Attendees will learn about FDA/EU Citations, ALCOA+ concept, audit trails in microbiology, and more. They will also gain an understanding of QBD approach, ICHQ14, ICHQ2(R1), and revalidation criteria. This course is essential for anyone looking to gain a better understanding of good laboratory practices.

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Course Overview

❗The content presented here is sourced directly from Udemy platform. For comprehensive course details, including enrollment information, simply click on the 'Go to class' link on our website.

Updated in [July 27th, 2023]

This course will provide an understanding of the different aspects of Good Laboratory Practices. Attendees will learn about data integrity in analytical and microbiology laboratories, including FDA/EU Citations, Non IT-Focus areas, IT-Focus areas, current trends of inspectors, and examples of data integrity. Additionally, the course will cover different guidelines on data integrity, evaluation of FDA warning letters and assessments, the ALCOA+ concept, audit trails in microbiology, and sterility tests. Furthermore, the course will cover analytical method validations, stability studies, out of specification and out of trend investigations, and common problem solving in analytical laboratories. The analytical method validation will include FDA expectations, QBD approach, QRM in analytical method validation, ICHQ14 - Analytical method development, ICHQ2(R1) - Analytical method validation, and overall evaluation and revalidation criteria. Finally, the course will cover human error investigation, including different types of human errors and how to investigate and avoid them.

Course Syllabus

Introduction

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