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Managing PAI and BIMO Inspection Readiness

Clarkston recently partnered with a client on a PAI and BIMO inspection readiness project. This client is a biopharmaceutical company focused on discovering, acquiring, developing, and commercializing therapeutic medicines designed to alleviate patient suffering from debilitating diseases with significant unmet medical need.

In early 2020, the company was preparing for FDA PAI and BIMO inspections for their first commercial product. To support this initiative, the organization engaged Clarkston to provide Project Management services for Inspection Readiness Activities. For Clarkston, this involved managing multiples action items lists to ensure all readiness activities were identified and completed in a timely manner.

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Clarkston assisted in identifying the logistical processes to be used for remote inspections, and managed several mock inspections done by consultants. Inspection support teams for both BIMO and PAI were trained and familiarized with logistics to be used during a fully remote inspection. Clarkston also provided back room and logistical support during the mock inspections, including documentation of finding and observations, and preparation of daily summaries for management. Additionally, Clarkston assisted in identifying all remediation activities from these inspections and monitored completion to ensure readiness for potential FDA inspections.  All identified remediation activities after mock inspections were tracked and completed prior to window for FDA inspections.

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Tags: Case Study, Project & Program Management, FDA Compliance