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Data Integrity requirements for Pharmaceuticals

Data Integrity in Analytical laboratories, in Microbiology laboratorie, Audit trial review, DI and Good doc. Practices
4.4
4.4/5
(2 reviews)
6 students
Created by Hitendrakumar Shah

9.4

CourseMarks Score®

10.0

Freshness

9.8

Feedback

7.7

Content

Platform: Udemy
Price: $11.99
Video: 5h 55m
Language: English
Next start: On Demand

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Detailed Analysis

CourseMarks Score®

9.4 / 10

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

Freshness Score

10.0 / 10
This course was last updated on 2/2021.

Course content can become outdated quite quickly.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

9.8 / 10
We analyzed factors such as the rating (4.4/5) 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: 8.5 / 10
The course includes 5h 55m 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: 9.2 / 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

Data Integrity is one of the basic GMP principles since years multiple Data Integrity citations were reported by FDA und European inspectors during the last 3 years. Many US Warning Letters and EU Non-Compliance Reports deal with serious Data Integrity violations. Data Integrity questions have been and will continue to be the focus of many GMP inspections. As a consequence international authorities – FDA, EMA, PIC/S, WHO, MHRA – published draft and final documents to describe the regulatory expectations of Data Integrity. Although all guidelines are not intended to impose additional regulatory burden to the regulated companies, a lot of uncertainty predominates the pharmaceutical industry how to implement these requirements into the daily business. The learning objectives are firstly, understand the data integrity requirements of a GMP regulated laboratory in  pharmaceutical organisations and contract labs and secondly, how laboratory personnel can ensure compliance and be able to defend their positions. Second person review is a critical process that needs to be thorough and effective to ensure that data issues are picked up and resolved. Hence, this course is designed in such a way that, the students will understand basics in data integrity and audit trail review, further they will understand very small difference between good documentation Practices requirements and data integrity requirements. There is specialised session to focus the data integrity requirements for analytical laboratories and  Microbiology laboratories.
Note that this course will focus only on hybrid and electronic systems and will not consider paper-based data integrity.

Requirements

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

You will learn

✓ This course has been updated to include brief understanding about data integrity requirements for pharmaceuticals with guideline requirements about data integrity, audit trail review, data integrity in production, data integrity in analytical laboratories and data integrity in microbiological laboratories

This course is for

• Pharmacy students, Pharmaceutical professionals, consultants. This course is essential for software vendors, auditors, and quality staff involved in GxP applications. • Regulatory Affairs • QA/ QC • IT/IS • Software Managers • Quality heads • Software vendors and suppliers

How much does the Data Integrity requirements for Pharmaceuticals 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 Data Integrity requirements for Pharmaceuticals course have a money back guarantee or refund policy?

YES, Data Integrity requirements for Pharmaceuticals 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 Data Integrity requirements for Pharmaceuticals 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).

9.4

CourseMarks Score®

10.0

Freshness

9.8

Feedback

7.7

Content

Platform: Udemy
Price: $11.99
Video: 5h 55m
Language: English
Next start: On Demand

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