Donald E. Zinn is the Director of Emerging Compliance at USDM Life Sciences.
Don provides validation and compliance leadership for USDM’s emerging clients with over 22 years of quality, compliance and systems validation experience. Don has experience working with various GXP organizations that provide services in the areas of blood banking, central laboratory testing, and clinical development. Don’s focus is assisting emerging clients 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 clients 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’s ability to rapidly analyze regulatory and validation landscapes allows him to provide risk-based solutions to emerging clients as well as Fortune 500 companies. Identifying and implementing company-wide workflow solutions that combine the best of client’s people, processes and technologies allows them to scale their business and deliver their solutions to market quicker, with low risk, while maintaining compliance.