Disclosure: when you buy through links on our site, we may earn an affiliate commission.

Computerised System Validation (CSV)

This course will take to understand practical approach towards validation requirements
3.7
3.7/5
(6 reviews)
30 students
Created by Hitendrakumar Shah

8.6

CourseMarks Score®

9.9

Freshness

7.6

Feedback

7.7

Content

Platform: Udemy
Price: $11.99
Video: 3h 41m
Language: English
Next start: On Demand

Top Pharmaceutical Industry courses:

Detailed Analysis

CourseMarks Score®

8.6 / 10

CourseMarks Score® helps students to find the best classes. We aggregate 18 factors, including freshness, student feedback and content diversity.

Freshness Score

9.9 / 10
This course was last updated on 1/2021.

Course content can become outdated quite quickly. After analysing 71,530 courses, we found that the highest rated courses are updated every year. If a course has not been updated for more than 2 years, you should carefully evaluate the course before enrolling.

Student Feedback

7.6 / 10
We analyzed factors such as the rating (3.7/5) and the ratio between the number of reviews and the number of students, which is a great signal of student commitment.

New courses are hard to evaluate because there are no or just a few student ratings, but Student Feedback Score helps you find great courses even with fewer reviews.

Content Score

7.7 / 10
Video Score: 8.1 / 10
The course includes 3h 41m video content. Courses with more videos usually have a higher average rating. We have found that the sweet spot is 16 hours of video, which is long enough to teach a topic comprehensively, but not overwhelming. Courses over 16 hours of video gets the maximum score.
Detail Score: 9.4 / 10

The top online course contains a detailed description of the course, what you will learn and also a detailed description about the instructor.

Extra Content Score: 5.5 / 10

Tests, exercises, articles and other resources help students to better understand and deepen their understanding of the topic.

This course contains:

0 article.
0 resource.
0 exercise.
0 test.

Table of contents

Description

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.

Requirements

• The person who is interested in learning should learn in focussed way to understand the concepts and practical approach.

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.

This course is 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

How much does the Computerised System Validation (CSV) course cost? Is it worth it?

The course costs $11.99. And currently there is a 52% discount on the original price of the course, which was $24.99. So you save $13 if you enroll the course now.

Does the Computerised System Validation (CSV) course have a money back guarantee or refund policy?

YES, Computerised System Validation (CSV) has a 30-day money back guarantee. The 30-day refund policy is designed to allow students to study without risk.

Are there any SCHOLARSHIPS for this course?

Currently we could not find a scholarship for the Computerised System Validation (CSV) course, but there is a $13 discount from the original price ($24.99). So the current price is just $11.99.

Who is the instructor? Is Hitendrakumar Shah a SCAM or a TRUSTED instructor?

Hitendrakumar Shah has created 3 courses that got 8 reviews which are generally positive. Hitendrakumar Shah has taught 38 students and received a 3.9 average review out of 8 reviews. Depending on the information available, Hitendrakumar Shah is a TRUSTED instructor.

More info about the instructor, Hitendrakumar Shah

Pharmaceutical Compliance Consultant,cGMP Trainer & Auditor
A Quality oriented professional with over 21 years of experience in Quality Assurance, Quality Control, Quality engineering, Quality auditor, pharmaceutical regulations and regulatory audit compliance.The area of expertise is as per the requirement of USFDA, EUGMP, PICS, MHRA, TGA, TPD, ANVISA, WHO & Schedule-M Guidelines.The key competencies include, Quality Compliance, Supplier Audit, build systems to encourage compliance with the principles of data integrity, computer system validation, Training, Risk assessment, Facing the audits, preparation and review of audit compliance, Qualification & validation, system development for CAPA effectiveness, stability studies & solving preapproval or post approval queries raised by regulatory agencies etc. · Independently handled – Quality assurance and Quality Control department for more than 13 years.· Audits faced- USFDA (7 times), ANVISA, MHRA, MCC, TGA,IDMA excellence, WHO audit, EU regulatory (8 times) , Yemen MOH, Digemid (Peru), Russian Authority audit etc.· Analytical Background: The analytical background includes, physical, chemical, microbiological testing of raw material, finished product & Stability samples. Handled the chromatographic instruments – HPLC, GC, IR, UV Visible spectrophotometer, AAS etc.· Technical support-o cGMP and data integrity gap audit.o Support in facing regulatory audits & compliance report reviewo Support in product development and/or regulatory submission or evaluation of readymade dossiers which can be used after site transfer for commercial manufacturing.· Expertise in GXP Computerised systems-o Major Software handled – Lab solution software, Empower 3 software, LIMS, TRIMS & Track wiseo Provide technical support to process owner during Computer system validation, Review of Computerised system validation documents for compliance, auditing the computer system supplier, performing GAP audit of Computerised systems, Evaluation of Computerised systems with respect to cGXP compliance , data integrity controls and ease of operating pragmatic approach· During tenure audited more than 500 vendors/suppliers and trained more than 5000 candidates. I am approved Auditor by the multinationals I worked and also I am CQI-IRCA Certified QMS/Lead Auditor as per ISO9001:2015).

8.6

CourseMarks Score®

9.9

Freshness

7.6

Feedback

7.7

Content

Platform: Udemy
Price: $11.99
Video: 3h 41m
Language: English
Next start: On Demand

Students are also interested in

Get this widget on your website (for course creators):

Computerised System Validation (CSV) rating
Copy this code and paste it to your website:
<a href="https://coursemarks.com/course/computerised-system-validation-csv/" target="_blank" title="Computerised System Validation (CSV) on Coursemarks.com"><img border="0" src="https://coursemarks.com/widget/86.svg" width="200px" alt="Computerised System Validation (CSV) rating"/></a>