Donna Gallien

Senior Consultant, GxPAssure

Donna D. Gallien is a highly experienced GCP Consultant and retired FDA Bioresearch Investigator with more than 30 years’ experience in quality assurance, auditing, regulatory compliance, and inspection readiness across FDA-regulated industries. She has conducted over 500 complex independent and joint FDA-regulated inspections and investigations, including clinical investigator sites, Institutional Review Boards, sponsor/monitor organisations, bioequivalence studies, biologics facilities, and human tissue operations. Her expertise includes domestic and international GCP audits, mock Bioresearch Monitoring Compliance Program inspections, site inspection readiness assessments, CAPA review, SOP and policy evaluation, and regulatory action support. Donna has also delivered GCP training to clinical research sites and sponsors and has supported FDA foreign inspection activities in Brazil, Canada, Germany, Italy, Japan, and Spain.

During her FDA career, Donna contributed to inspections leading to regulatory and administrative actions, including Untitled Letters, Warning Letters, regulatory meetings, rejection of data, and initiation of disqualification proceedings. She has reviewed and analysed policies, procedures, quality systems, manufacturing and clinical operations, complaint investigations, corrective and preventive actions, and technical documentation to assess compliance with applicable Food, Drug & Cosmetic Act requirements and 21 CFR regulations. Her background also includes biologics and blood bank inspections, donor eligibility and suitability evaluations, GMP and good tissue practice assessments, product complaint investigations, emergency response leadership, and training of new and experienced investigators.

Key Skills and Experience

• GCP auditing, clinical trial compliance, site inspection readiness, and mock BIMO inspection support.
• Extensive FDA inspection and investigation experience across Bioresearch, biologics, blood donor centres, plasmapheresis centres, tissue banks, and transfusion facilities.
• Regulatory compliance assessment against FDA requirements, the Food, Drug & Cosmetic Act, and 21 CFR regulations.
• Quality assurance activities including internal audits, supplier/vendor audits, product complaint handling, CAPA review, and SOP/policy evaluation.
• Clinical investigator, IRB, sponsor, monitor, sponsor-investigator, and bioequivalence study inspection expertise.
• International inspection experience as part of the FDA Foreign Inspection Cadre across multiple countries.
• Training and mentoring of investigators, clinical research sites, sponsors, and regulatory teams on GCP and inspection readiness.
• Leadership experience in supervisory details, emergency response coordination, incident management, and public affairs outreach.