Peter V. LindsayPeter V.Lindsay

Led comprehensive review of supplier management processes and controls for multinational medical device manufacturer.

Conducted risk assessment of manufacturing site’s data integrity controls for API facility located in India.

Advised pharmaceutical company in preparation for an FDA inspection of its drug safety reporting program and processes.

Conducted internal review for medical device manufacturer responding to whistleblower allegations of GMP and data integrity violations.

Conducted global review of controls related to data management at multiple European and Asian manufacturing facilities for large pharmaceutical company.

Led review of controls and practices related to the management of deviations, out-of-specification investigations, complaints, and CAPAs at multiple global sites of pharmaceutical company.

Assisted medical device company in responding to an FDA Warning Letter for GMP issues, developing corrective action plan, and meeting with FDA District Office; Warning Letter was successfully closed out in less than one year.

Advised U.S.-based medical device company on response to FDA Warning Letter, execution of related product recalls, and development of quality system remediation plan for imaging device.

Assisted European-based food manufacturer in responding to FDA inspection observations.

Conducted GMP readiness reviews and/or prepared many manufacturing sites for FDA inspections in the United States, Canada, Mexico, China, India, Japan, Thailand, Belgium, Croatia, France, Germany, Italy, and other locations for pharmaceutical, medical device, and biotech companies.