Understanding 21 CFR 210 and 211

Course 0712 - 2 Days - 1.4 CEUs

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Key Session Topics

Why the GMPs were developed
Understanding the intent of the GMPs
Detailed overview of the GMPs
Developing the necessary skills to implement the GMPs within your organization
Examining your current activities in the light of the GMP
Determining how the GMPs will benefit your procedures and how to show others the advantages available
Maximizing the benefits of employing the GMPs
Verifying that regulations are satisfied
Adequately preparing for the next FDA audit; what the FDA looks for

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Course Objectives
This two-day course provides attendees with an understanding of the background and intent of the GMPs. Through the course, you will learn how to implement the GMPs in your organization, how to optimize their benefits and meet regulations.

Who Should Attend

Product development scientists and technicians
Quality control/assurance personnel and management
Regulatory affairs personnel
Manufacturing management and personnel
Quality system implementation teams
Designated FDA contacts