Showing 1-10 of 40 results

cGMP for (Bio)Pharmaceuticals

September 29, 2021
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This lecture-based, 3-hour live webinar course covers 21 CFR Parts 210, 211, and 600. Topics include the current Good Manufacturing Practices (cGMPs), regulatory compliance, and maintaining a culture of quality …

Navigating the Pre-IND Pathway

September 22, 2021
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In the early stages of the pharmaceutical drug approval process, it is essential to maximize outcomes of the Pre-Investigational New Drug (IND) meeting with FDA. Understanding how to navigate initial …

Navigating the Pre-IND Pathway

July 15, 2021
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In the early stages of the pharmaceutical drug approval process, it is essential to maximize outcomes of the Pre-Investigational New Drug (IND) meeting with FDA. Understanding how to navigate initial …

Writing Controlled Documents

May 19, 2021
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Current Good Manufacturing Practices (cGMPs) in a regulated industry require the use of controlled documents. Participants in this course will learn strategies for designing and writing controlled documents, with the …

cGMP for Dietary Supplements

September 9, 2020
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The FDA regulates both finished dietary supplements and dietary ingredients to ensure they are appropriately labeled, and safe for the consumer. Described in 21 CFR 111, these regulations provide for …