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Introduction

This webinar will examine the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and its compliance to the cGMPs, especially CAPA. It will examine how these goals of the Agency have translated into action in the past half year, with trends evident in 483 observations and Warning Letters. A key to effective relations with the FDA is the emphasis on proving a company is "in control" to an investigator's satisfaction, which has to center on CAPA. So the webinar will address the development of a new, or revision of an existing CAPA SOP to ensure it meets those goals.

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Venue

Online Training Webinar

Online Training Webinar, United States

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Organised by

GlobalCompliancePanel

Contact information

Mr Manzoor
United States of America
800-447-9407
Contact us by email

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