Part 11 Compliance for Computerised Systems

Course Feature

Cost

Paid
Provider

Udemy
Certificate

Paid Certification
Language

English
Start Date

2021-04-20
Learners

No Information
Duration

No Information
Instructor

Hitendrakumar Shah

Add to Favorites

3.0

188 Ratings

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.

Show All

Go to class

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.

Course Syllabus

Introduction

Show All

Recommended Courses

Computer Aided Drug Design (CADD) from A to Z

4.2

Udemy 117 learners

Learn More

This course provides a comprehensive overview of Computer Aided Drug Design (CADD) from A to Z. It is suitable for anyone who wants to learn the basics and concepts of drug discovery and design drugs from scratch. Learners will gain an understanding of the relationships between physico-chemical properties of drugs and their biological activities, as well as the types of interactions between drugs and receptors. They will also be familiar with modern techniques such as computer-based methods of quantitative structural activity relationship QSAR and molecular graphics. This course covers all aspects of drug discovery, from sources of lead compound to drug latentiation (prodrug), and is perfect for anyone looking to gain a comprehensive understanding of CADD.

The Pharmaceutical R&D Process in Healthcare

4.5

Udemy 1,264 learners

Learn More

This course provides an in-depth understanding of the pharmaceutical R&D process in healthcare. Through lectures, quizzes, activities, and opinion questions, learners will gain an understanding of how drugs are discovered, developed, and marketed, and the role of the FDA. It is designed for anyone considering a career in the pharmaceutical industry or anyone who would like to know more about the process. Learners will be able to evaluate job descriptions, select the appropriate career training courses and conferences, and confidently discuss opportunities with career counselors, recruiters, and people working in the pharmaceutical industry. This course is perfect for those looking to gain a comprehensive understanding of the pharmaceutical R&D process in healthcare.

Computerised System Validation (CSV)

3.8

Udemy 1,274 learners

Learn More

This course provides a comprehensive introduction to Computerised System Validation (CSV) for new learners. It covers topics such as categorisation of software and hardware as per GAMP 5, different validation strategies, developing URS, FRS, FAT, SAT, IQ, OQ and PQ, test strategies, validation master plan and validation master report concept, and common questions and answers. It is beneficial for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors, as well as software vendors, auditors, and quality staff involved in GxP applications. This course explores tried, tested, and internationally recognized methods of meeting regulatory requirements for computerized systems in the pharmaceutical industry. Click now to learn more!

eCTD & CTD Preparation & Submission Course

4.1

Udemy 3,331 learners

Learn More

This eCTD & CTD Preparation & Submission Course is the perfect way to gain a comprehensive understanding of the Electronic Common Technical Document (eCTD) specification. Learners will gain an understanding of the creation of an eCTD submission, and an overview of regional differences in dossiers. Upon completion of the course, learners will receive a certificate of completion and be equipped with the knowledge to pursue job opportunities in Regulatory Affairs, such as Regulatory Affairs Associates, Regulatory Affairs Assistance, Regulatory Affairs Head/Director, and Medical Information. This course is a valuable training and reference tool for those new to the use of the format, and can be of assistance to anyone involved with electronic submissions and navigating changing requirements. Don't miss out on this great opportunity to gain the skills and knowledge needed to pursue a career in Regulatory Affairs.