Our Subject Matter Experts
Director of Emerging Compliance
Don provides validation and compliance leadership for USDM’s emerging customers with over 22 years of quality, compliance, and systems validation experience. Don has experience working with various GxP organizations that provide services in blood banking, central laboratory testing, and clinical development. Don’s focus is on assisting emerging customers in the life sciences industry to become compliant with best industry practices and regulatory guidelines while minimizing risk to patients and data.
As a Certified Quality Auditor (CQA), Don has over 20 years of experience applying quality and compliance-focused solutions to customers who perform phase I-IV clinical trial development activities including internal and vendor auditing, SOP authoring, QMS compliance, IT Infrastructure, and systems compliance. He has directed multiple computer systems validation (CSV) projects for quality management systems (QMS), Electronic Data Capture (EDC) systems, Electronic Trial Master File systems (ETMF), Safety, Biostatistics, and Helpdesk solutions. Don is a subject matter in the areas of 21 CFR Part 11 and data integrity regulations.
Don currently resides in NE Florida. He enjoys surfing and deep-sea fishing, playing golf, and cooking with his family.
Don’s projects at USDM include:
- Active Validation Lead: managing the initiation and execution of technology partner validation services for commercial off-the-shelf (COTS) systems such as Veeva Clinical, Regulatory and Quality solutions; including demonstration of validation expertise to sponsors.
- Provide subject matter expertise and execution of solutions for GxP customers with regards to quality, systems validation, change management, and regulatory compliance.
- Oversee the change management lifecycle of active USDM quality management documentation inclusive of Quality, Validation, and Information Technology artifacts.
- Plan and execute vendor audits of GxP companies and software solutions on behalf of USDM and sponsors inclusive of TraceLink, Valiance, Prevail, Cenduit, ComplianceWire, and Veeva Systems Inc.