The Eolus team has over 25 years in the Quality Systems, Software, and Information Technologies. Eolus has experience designing, evaluating, selecting, building and implementing a wide variety of systems for life science and information technology industries worldwide.
Our principals have extensive experience in software, quality systems, and information technology. We provide audit and management consulting services worldwide.
CEO, Principal Auditor and Quality Systems Consultant
As Principal Consultant and Auditor for Eolus Compliance Solutions LLC, Ms. Weldon provides systems, and quality consulting and audit services to pharmaceuticals, medical device, biotech, diagnostic, IVD, and life sciences organizations worldwide. Phyllis M. Weldon has over 30 years of pharmaceutical, medical device, clinical research and biotech experience.
Her experience includes full quality systems audits, ISO and QSR training courses including 21 CFR Part 11, ICH GCP, GDPR and HIPAA compliance. She has led quality systems implementation projects at various organizations worldwide.
Ms. Weldon previously served as the Chief Information Officer for Duke Clinical Research Institute. Prior to Duke, her experience included nine years at Burroughs Wellcome Company where her accomplishments included implementation of an enterprise clinical trial management system. After leaving Wellcome, she founded a consulting company and served as an international project manager and consultant for several life science companies and clinical research organizations.
She was a co-founder and Vice President of Product Development and Chief Technology officer for DataScout Software, which developed and patented technology for Interactive Voice Response technology for patient enrollment and randomization in clinical trials. Prior to DataScout, Ms. Weldon served as the Vice President of Quality Systems Compliance Services at SEC Associates.
Ms. Weldon has a strong project management background, a thorough understanding of medical devices, clinical research, design controls, CAPA, FMEA, process design, systems quality assurance, systems development life cycles and validation methodologies, as well as privacy and security. Her experience includes Mock FDA Inspections, vendor evaluations and audits, independent assessments and gap analysis, full quality systems audits, validation and training. She is ANSI-RAB accredited lead auditor trained for ISO9000/9001.
Phyllis has been a presenter at Barnett, DIA and PDA meetings on topics relating to project management, and regulatory compliance. She is a published author including articles in the Quality Assurance Journal. She served on the PDA task force, which published the Good Electronic Records Management (GERM) Documents.
Ms. Weldon was the author/co-editor of the Barnett Good Clinical Practice Guide 2020/2021 for Chapter 10, FDA Inspections, Quality Assurance Activities and Auditing. Prior to that, Ms. Weldon served on DIA Peach (previously Red Apple) task forces which produced “Current Concepts in Validation and GLP Compliance, Computerized Systems Used in Non Clinical Safety Assessment” 2007, and “GCP System and Data Integrity for Clinical Trials”, 2008.
For Additional Consultant CVs contact us.