Donna McElcar - Quality Assurance

Donna McElcar, MS, RQAP-GCP is President and Lead Consultant of Clear CQA LLC. Clear CQA provides clear quality assurance advice and services to clinical research providers within the pharmaceutical and medical device industry. Donna has over 20 years of experience in the quality assurance field. She has an extensive and broad background working within small and mid-size CROs, a software vendor, a medical device Sponsor company and as an independent consultant. She provides consulting services by performing gap analysis, QMS infrastructure design and redesign, and inspection preparation activities. She is also skilled at conducting audits of a variety of vendors, investigator sites, computerized systems and internal process/systems. She has a Master of Science in Clinical Research and has been an active member of the SQA and the NCCSQA since 2002. She has been a Registered Quality Assurance Professional in Good Clinical Practices (RQAP-GCP) since 2008.
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