Your Trusted and Proven Partner for Global GxP Quality Compliance
Rely on Advarra to establish, plan, review, or correct any GxP quality requirements for your current and future studies. With a flexible engagement model, collaborative approach, and established reputation, Advarra can support GxP excellence in research organizations of any size around the world.
GxP Services Team

Abraham Seckler
Managing Director of GxP Services
Abraham Seckler has over two decades of experience in quality and R&D, specializing in strategically integrating quality into clinical operations while aligning with company goals. Over his career, Abraham has effectively deployed Quality strategies to best meet the needs of businesses ranging from Fortune 500 companies to startups.

Jay Westfall
Director of GCP Services
Jay Westfall brings years of healthcare industry experience to Advarra, which includes 36+ years in biomedical device and pharmaceutical industries, 30+ years of QA experience, 20+ years as an independent contract clinical and regulatory compliance auditor, and 8+ years of managerial experience. He has extensive knowledge about operational auditing, system auditing, and compliance. Westfall has conducted over 1,000 audits (GCP, GVP, GCLP, CSV) since 1994, with 100+ audits in the country of India.

Amanda Bourgeois, BS, MS, CQA
Director of GxP Services
Amanda Bourgeois is an ASQ certified CQA professional with 25 years of GxP experience in the pharmaceutical industry. She has provided operational quality leadership for pharmaceutical and biotech companies of all sizes. Bourgeois has expertise and working knowledge of quality assurance, process management, risk management and application of GMP, GCP, and GLP regulations. She has been a key contributor in several projects, including the development of SOPs, gap analyses, auditing, guidance on corrective and preventive action (CAPA) management, and overall Quality Management System/Quality Department management.

Lella Baker, BA, MDiv, CQA
Sr. Consultant of GxP Services
Lella Baker is an ASQ certified auditor with 15 years of experience working for CRO, sponsor, and post-market pharmacovigilance companies. She is experienced in audit and inspection hosting, including running backrooms, conducting training on GxP requests, and CAPA management. Baker has led GCP, GVP, TMF, and ISA audits across multiple therapeutic areas and trial phases in the US, Canada, UK, and EU.
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Frequently Asked Questions
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