Data Integrity requirements for Pharmaceuticals

Course Feature

Cost

Paid
Provider

Udemy
Certificate

Paid Certification
Language

English
Start Date

2021-02-20
Learners

No Information
Duration

No Information
Instructor

Hitendrakumar Shah

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3.6

164 Ratings

This course provides a comprehensive understanding of the data integrity requirements for pharmaceuticals. It covers topics such as GMP principles, FDA and European inspector citations, US Warning Letters and EU Non-Compliance Reports, and international authority guidelines. Learners will gain an understanding of the data integrity requirements of a GMP regulated laboratory in pharmaceutical organisations and contract labs, and how laboratory personnel can ensure compliance and be able to defend their positions. The course also covers basics in data integrity and audit trail review, as well as the differences between good documentation Practices requirements and data integrity requirements. Specialised sessions focus on data integrity requirements for analytical laboratories and Microbiology laboratories. Join this course to gain a comprehensive understanding of data integrity requirements for pharmaceuticals.

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Course Overview

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Updated in [July 27th, 2023]

This course provides learners with an understanding of the data integrity requirements for pharmaceuticals. It covers topics such as GMP principles, FDA and European inspector citations, US Warning Letters and EU Non-Compliance Reports, and international authority guidelines. The learning objectives are to enable learners to understand the data integrity requirements of a GMP regulated laboratory in pharmaceutical organisations and contract labs, and how laboratory personnel can ensure compliance and be able to defend their positions. The course also covers basics in data integrity and audit trail review, as well as the differences between good documentation Practices requirements and data integrity requirements. Specialised sessions focus on data integrity requirements for analytical laboratories and Microbiology laboratories. The course focuses only on hybrid and electronic systems and does not consider paper-based data integrity.

Course Syllabus

Data Integrity Requirements for Pharmaceuticals

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