GMP/Quality System Regulation (QSR) Enforcement and Compliance

• Advised pharmaceutical API company on developing comprehensive remediation plans to address Warning Letters related to multiple international sites.
• Represented Asia-based pharmaceutical manufacturer to respond to significant FDA Warning Letter raising data integrity issues and on related investigation and remediation plan.
• 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.

Regulatory and Enforcement Counseling

• Advised multinational pharmaceutical company in criminal and civil investigation which resulted in DOJ declination to intervene in a whistleblower action related to allegations of off-label promotion.
• Assisted pharmaceutical manufacturer with review and remediation planning related to device tracking issues.
• Conducted an internal review focusing on potential off-label marketing practices by field sales representatives for pharmaceutical manufacturer.
• Led internal reviews for global pharmaceutical manufacturer regarding field promotional practices, including issues related to product reimbursement and potential off-label promotion.
• Conducted FDA-related due diligence for corporate transactions related to the purchase of multiple pharmaceutical API manufacturing sites.
• Advised pharmaceutical manufacturer in preparing for post-market safety inspections and related communications with FDA.
• Assisted pharmaceutical manufacturers with issues related to drug sampling.

• Panelist, FDLI Enforcement, Litigation, and Compliance Conference, Continuing Impact of FDA's Inspection Approach on Industry and What Happens Next, December 9, 2021
• Speaker, FDLI Introduction to Drug Law, GMPs and Manufacturing, November 10, 2021
• Warning Letters and What They Mean for Healthcare Lending, Peter Lindsay and Stacy Hopkins, Medical Device and Diagnostic Industry (MDDI), July 9, 2021
• Panelist, FDLI Annual Conference, Supply Chains in a Post-Pandemic World, May 19, 2021
• Key Considerations for Senior Executives Related to Quality Culture, Peter Lindsay and Nathan Sheers, Pharmaceutical Executive, March 9, 2021
• 3 Things To Know About FDA's Evolving Drug Inspections, Peter Lindsay and Nathan Sheers, Law360, Feb. 19, 2021
• Going Up the Chain: Escalation of Significant Issues in Life Sciences Companies, Peter Lindsay, Nathan Sheers, and Jesselyn Pe, FDLI Update Magazine, Spring 2021
• Presenter, "Regulation of Drug Manufacturing," Introduction to U.S. Drug Law and Regulation, Food and Drug Law Institute (Apr. 13, 2018)
• Trainer, DIA course for foreign regulators on "Drug GMPs and Inspections – A Legal Perspective" (March 2013)
• Presenter, DIA Webinar on "Pharmacovigilance and Social Media" (January 2010)
• Presenter, FDA CDER In-House Training Program on "Introduction to Drug Law and Regulation: Regulation of Drug Manufacturing" (Dec. 2009)