Details

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Course Objective:

• Overview of the FDA and intention of the 21 CFR Part 820 Quality System Regulation (QSR)
• To understand the up-to-date requirements of 21 CFR Part 820 QSR and other Parts such as Part 11, Part 803 and Part 821
• Working knowledge in application of the requirements
• Preparation for FDA inspection

Duration:

2 days

Suitable for:

This course is designed for ALL functions and levels of an organization who need to gain some basic understanding of the US FDA 21 CFR Part 820 requirements. A value-added course for those working with regulatory compliance and involved in regulatory inspection.

Contact us for the synopsis.