Eolus Team

Eolus® Compliance Solutions : Team

The Eolus team has over 25 years in the pharmaceutical, healthcare and software industries. Eolus has experience designing, selecting, building and implementing a wide variety of life science systems.

Eolus provides systems, regulatory and consulting solutions to the BioPharma Industries. Our principals have extensive experience in biotech, pharmaceutical, clinical research, and healthcare, including domestic and international companies.

CEO, Principal Consultant and Auditor

As Principal for Eolus Compliance Solutions, Ms. Weldon provides systems, and quality consulting and audit services to pharmaceuticals, medical device, biotech, diagnostic, IVD and life sciences organizations worldwide. Her recent experience includes vendor compliance assessments, full quality and systems audits, and conducting ISO and GXP training courses including 21 CFR Part 11 compliance. She has recently led quality systems implementations, and implementations of SDLC and software validation methods and processes.

Ms. Weldon has a strong project management background, a thorough understanding of product design, design control, process control, QSR, cGMPS, GLP, GCP, ISO, ICH, SDLC, project management methodologies, and software validation methodologies. In addition, Ms Weldon has experience in a wide variety of systems from clinical trials project management, drug supply and distribution, IVRS/IWRS, EDC, eDiaries, ePRO, eClinical, clinical data management, LIMS, instrumentation systems, inventory control systems to ERP, training, financials, and HR.

Ms Weldon has a strong information systems background which includes software design and development, database design, regulatory compliance, product and system development life cycle methodologies, business process design, and software validation.

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 focused and published the Good Electronic Records Management Document. Ms. Weldon serves on the DIA Peach (previously Red Apple) task force on Computerized Systems in Clinical Trials, “Current Concepts for Data Integrity”

As previous Chief Information Officer for Duke Clinical Research Institute, with responsibility for the software applications and computing infrastructure to support all clinical research activities, she provided systems for clinical trial management, clinical supply manufacturing, inventory, distribution tracking, site management, randomization and enrollment, document management and clinical data management.

Subsequent to Duke, she served as Vice President of Compliance Services for SEC Associates, a regulatory compliance company focused on the pharmaceutical, medical device, IVD, biotech and healthcare industries. Ms. Weldon’s experience includes nine years at Burroughs Wellcome Co. While at Wellcome, her focus was leading major development and process improvement projects for enterprise systems and for clinical trial management. After leaving Wellcome, she founded a consulting company.

As a consultant, she has serves in quality systems roles for major pharmaceutical companies and medical device companies. Ms. Weldon provides systems and regulatory consulting services to pharmaceutical companies, medical device, and clinical research organizations worldwide.

For Additional Consultant CVs contact us.

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