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!
You may also like
- Top and Best Laravel Admin Panel With Projects
- Build 10 C# Beginner Projects from scratch
- Become a video game developer with Gamemaker Studio 2.3
- NVDA all the way
- Complete Git and Github Beginner to Expert
- Build 10 JavaScript Projects in less than 6 Hours .
- (NEW)Learn to Code and Build Real World Projects-2023
- [2024] Svelte.js 4.2.17 The Complete Practice Tests SvelteJS
- Complete Kotlin Design Patterns masterclass
- Advanced Machine Learning in iOS, Swift, Create ML, Core ML
- RxJava | RxAndroid – III
- C++ STL Standard Template Library + DSA Interview Questions
- OAuth 2.0 Deep Dive Volume 1
- Master NestJS a Node.js Framework 2024
- Java for Beginners
- Apply Jobs as MERN stack developer with this course
- Android Game Development : Endless Runner Game in Android
- What’s New in .NET 7 and C# 11
- WordPress Theme Development With ACF : For Themeforest
- Python Django Crash Course | Build Real World Web Apps