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Part 11 Compliance for Computerised Systems

Learners: 188

Instructor: Hitendrakumar Shah

Duration:

This course provides a comprehensive overview of Part 11 Compliance for Computerised Systems. It covers USFDA 21 CFR Part 11, EUGMP Annex 11, and Data Integrity requirements. Through discussion and learning videos, you will learn how to design systems and processes to ensure compliance, audit preparedness, and common errors to avoid. This course is essential for any pharmaceutical company looking to ensure their computerised systems are Part 11 compliant.▼▲

Course Feature Course Overview Course Provider

Go to class

Course Feature

Cost:

Paid

Provider:

Udemy

Certificate:

Paid Certification

Language:

English

Start Date:

2021-04-20

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 provides an overview of Part 11 Compliance for Computerised Systems. It covers the USFDA 21 CFR Part 11, EUGMP Annex 11, and key aspects of data integrity. Through discussion, participants will gain an understanding of the broad requirements of Part 11, the application of the guide, and the overall approach to Part 11 compliance. Additionally, the course will explain the data integrity requirements, including FDA citations, introduction to data integrity, how to design systems and processes to assure data integrity, controlling master templates, and practical implementation. The course also covers audit preparedness for computerised systems and common errors companies make when ensuring Part 11 compliance. Upon completion, participants will have the knowledge to claim their computerised system as Part 11 compliant.