With over 40 years in the Medical Device, Pharmaceutical and Life Sciences industries, Beverly has extensive experience in manufacturing controls supporting the sterile label claim. Beverly will assist you with your sterilization strategy for new product introductions and product line extension as well as supporting regulatory remediation and CAPA programs while focusing on cost effective sterilization supply chain optimization. As a Certified Industrial Sterilization Specialist for Ethylene Oxide and Radiation Sterilization Technologies and an active member of AAMI Sterilization Standards Committee Working Groups she brings expert project management and validation program skills to your team.
Core expertise includes Regulatory Compliance Programs – remediation and regulatory responses, Internal and Supplier Audit Programs, CAPA and complaint handling system development with emphasis on US, European Markets and MDSAP country requirements.
She brings over 30 years of experience as a Lead Assessor for supplier, internal audits as well as MDSAP and MDD/IVDD Notified Body Assessor background to assist you with your corrective action programs.
Academic & Professional Qualifications:
- BS, Microbiology, Clemson University
- MBA, Operations Management, University of South Carolina Moore School of Business
Training, Quality Systems, & Specialties:
- ISO 11135 – Ethylene Oxide
- ISO 11137 – Radiation
- Medical Device Directive (MDD)
- ISO 13485
- 21 CFR, Subchapter H (Medical Devices)