Inspection Readiness & Response

Foresight has extensive experience conducting drug safety mock inspections, responding to FDA Form 483 findings and/or other inspectional observations, establishing remediation timelines, and implementing corrective and preventative actions (CAPA). Foresight’s proven methodology for conducting PV audits includes evaluation of:

Drug safety SOPs – A review of SOPs for collection, assessment, reporting and analysis. These documents address AEs, risk management, surveillance, training, quality management, and interfaces with third parties such as CROs and business partners to ensure alignment with FDA standards. Drug safety business processes – A review of all business processes (AEs, risk management, surveillance, training) executed by drug safety team members to ensure compliance with corresponding SOPs.

Safety system documentation – Documentation that supports the system development lifecycle (SDLC) for systems that support drug safety will be evaluated for compliance with industry standards. Linkages with third parties, e.g. CROs and licensing partners – A sample of third-party agreements are assessed for completeness and clarity regarding responsibilities for collection, assessment, and reporting of AEs.

Training records – A sample of training records are evaluated for accuracy and completeness.
Drug safety business processes – A review of all business processes (AEs, risk management, surveillance, training) executed by drug safety team members to ensure compliance with corresponding SOPs.

Linkages with third parties, e.g. CROs and licensing partners – A sample of third-party agreements are assessed for completeness and clarity regarding responsibilities for collection, assessment, and reporting of AEs.