FDA Form 483s are used to document the findings of FDA investigators or other FDA authorized inspectors after their inspection and evaluation of manufacturing and control practices associated with FDA-regulated products. Warning Letters are issued to top management of FDA-regulated companies following inspections in which the agency determines that serious violations have occurred.
Proper interpretation and understanding of the contents and phrasing of FDA Form 483 observations and Warning Letters is critical to preparing effective responses and post-inspection plans.
This course will provide examples to illustrate good techniques in reviewing and responding to FDA Form 483s and Warning Letters.
- Understanding of FDA Form 483
- Understanding of Warning Letter
- Tips for developing effective responses
- Tips for writing effective responses
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