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Compliance with 21 CFR 211.110: A Comprehensive Guide

$9.99

This course offers in-depth insights into the FDA’s draft guidance on 21 CFR 211.110. Learn how to ensure batch uniformity and drug product integrity using advanced manufacturing techniques. Explore the integration of process models into control strategies to meet regulatory standards.

In this course you will learn the following:
* Understand the key requirements of 21 CFR 211.110 for drug product manufacturing.
* Identify the role of advanced manufacturing techniques in ensuring product quality.
* Recognize the importance of process models in manufacturing control strategies.
* Comprehend the FDA’s support for pharmaceutical innovation and modernization.

NOTE: Unless otherwise indicated, all course purchases are for access to the course for a period of 1-year.  At the end of the one year term, the course will be set to “inactive”. 

SKU: FR-25-379-1 Categories: , , , Tags: , Course: Compliance with 21 CFR 211.110: A Comprehensive Guide
SKU: FR-25-379-1 Categories: , , , Tags: , Course: Compliance with 21 CFR 211.110: A Comprehensive Guide

Why This Course is Important
A thorough understanding of how to implement FDA’s guidance on batch uniformity and drug product integrity, which is crucial for maintaining compliance and ensuring high-quality production in the pharmaceutical industry.

Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Considerations for Complying With 21 CFR 211.110; Draft Guidance for Industry; Availability.

Key regulatory references include:

Course SKU
FR-25-379-1

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