Category: Product Complaints & Adverse Events

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Product Complaints and Adverse Event

Created by: Kimberly Wallbank & Nicole Damour Product complaints and reports of adverse events are unwelcome events at any company, especially if a product recall must be considered. However, these must be handled promptly and with all due diligence to prevent authentic drug- related events from negatively impacting the health and well-being of patients. This […]

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High Stakes Change Management: Remediation Post FDA Warning Letter

Created by: Chris Gray, Principal Consultant, CAI Your company has received an FDA warning letter, now what? As an organization finds itself in uncharted waters due to inspection results, the leader’s job is to chart a course and speed to re-inspection success without everyone jumping ship. Leaders must remember historical averages for change success hovers […]

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