Computerised System Validation (CSV)

Computerised System Validation (CSV), available at $49.99, has an average rating of 3.8, with 5 lectures, based on 333 reviews, and has 1518 subscribers.

You will learn about Pharmacy, This course has been updated to include the update on 21 CFR Part 11 and also electronic version of CFR part 11. This two-day fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. Regulatory guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements. The course will provide principles and an overview of the overall computer systems compliance. This course is ideal for individuals who are Pharmacy students, consultants who are doing computerised system validation, This course is essential for software vendors, auditors, and quality staff involved in GxP applications. • Regulatory Affairs • QA/ QC • IT/IS • Software Managers • Project Managers • Software vendors and suppliers It is particularly useful for Pharmacy students, consultants who are doing computerised system validation, This course is essential for software vendors, auditors, and quality staff involved in GxP applications. • Regulatory Affairs • QA/ QC • IT/IS • Software Managers • Project Managers • Software vendors and suppliers.

Enroll now: Computerised System Validation (CSV)

Summary

Title: Computerised System Validation (CSV)

Price: $49.99

Average Rating: 3.8

Number of Lectures: 5

Number of Published Lectures: 5

Number of Curriculum Items: 5

Number of Published Curriculum Objects: 5

Original Price: ₹1,999

Quality Status: approved

Status: Live

What You Will Learn

Pharmacy,
This course has been updated to include the update on 21 CFR Part 11 and also electronic version of CFR part 11. This two-day fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. Regulatory guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements. The course will provide principles and an overview of the overall computer systems compliance.

Who Should Attend

Pharmacy students, consultants who are doing computerised system validation, This course is essential for software vendors, auditors, and quality staff involved in GxP applications. • Regulatory Affairs • QA/ QC • IT/IS • Software Managers • Project Managers • Software vendors and suppliers

Target Audiences

Pharmacy students, consultants who are doing computerised system validation, This course is essential for software vendors, auditors, and quality staff involved in GxP applications. • Regulatory Affairs • QA/ QC • IT/IS • Software Managers • Project Managers • Software vendors and suppliers

This course has been updated to include the update on 21 CFR Part 11 and also electronic version of CFR part 11. This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements.

Regulatory guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements.

The course will provide principles and an overview of the overall computer systems compliance. This course includes categorisation of software and hardware as per GAMP 5, the different validation strategies etc. More discussion will be on developing URS, FRS,FAT,SAT,IQ,OQ and PQ. This session will explain you further the test strategies specifically black box strategies so that the validation person can easily do the validation by following the instructions given in this video.

In this learning session, we will clear your validation master plan and validation master report concept. Lastly some common questions by many experts and answer to these questions are available at the last of session.

Training Course will benefit all who use cGXP computerised systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications.

Course Curriculum

Chapter 1: Computerised System Validation

Lecture 1: Quality Risk Management

Lecture 2: 21 CFR Part 11

Lecture 3: EUGMP Annex 11 Expectations and Requirements

Chapter 2: Computerised System Validation

Lecture 1: Computerised System Validation

Lecture 2: Inspection Readiness for cGXP Computerised Systems

Instructors

Hitendrakumar Shah
Pharmaceutical cGMP Compliance Consultant, Trainer & Auditor

Rating Distribution

1 stars: 15 votes
2 stars: 18 votes
3 stars: 75 votes
4 stars: 120 votes
5 stars: 105 votes

Frequently Asked Questions

How long do I have access to the course materials?

You can view and review the lecture materials indefinitely, like an on-demand channel.

Can I take my courses with me wherever I go?

Definitely! If you have an internet connection, courses on Udemy are available on any device at any time. If you don’t have an internet connection, some instructors also let their students download course lectures. That’s up to the instructor though, so make sure you get on their good side!

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