FDA Audit Preparation

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• FDA cGMP online training courses, programs, and classes offered by SkillsPlus International Inc.

The folks from Emergo Group have a very nice outline of how to think and approach FDA inspection readiness, before the FDA actually shows up at your door.

Preparation for an FDA Quality System Audit - from Emergo Group:

"In order to meet US Food and Drug Administration (FDA) requirements, medical device manufacturers active in the US market must undergo FDA audits of their quality management systems to demonstrate compliance with Quality System Regulation 21 CFR Part 820, also known as Good Manufacturing Practice (GMP)."

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FDA Promises Swift-Aggressive Enforcement To Protect Public Health

• Respected FDA GMP online training courses and programs by SkillsPlus International Inc.

The Food and Drug Administration (FDA) is articulating its enforcement strategy in order to ensure strategic alignment within the Agency and express why enforcement is critical to protecting public health. The FDA has the responsibility and authority to safeguard the public health and ensure compliance with the laws and regulations it administers pertaining to foods, drugs, medical devices, biologics, and tobacco products.

Enforcing the laws and regulations is one of the Agency’s highest priorities. The FDA is committed to swift, aggressive enforcement actions to protect the public health.

Under the FDA's scrutiny, it's important more than ever before that drug and device manufacturers have their house in order.  Getting a house in order also includes paying attention to executive and operator training around the FDA regulations, such as cGMP regulations and more.

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Updated March 10, 2022

The original link broke.

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PART 58 - GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES

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If you're responsible for delivering GLP training, then read this helpful article, "A Summary of Glp Training Regulation Requirements in 21 Cfr Part 58: Associated Complications and Solutions." It's important to think about some of the solutions and associated ramifications for the training approach you're going to choose. 

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