Helping Companies Reach Compliance Goals Since 2005

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Stephanie Skipper – Founder & Principal Consultant

Stephanie Skipper is the Founder and Principal Consultant of Ticalion Quality Management Services, which serves clients nationwide from its headquarters in Chesapeake, Virginia.

Stephanie is a Quality System Subject Matter Expert with 15 years of pharmaceutical industry experience and more than 10 years of direct, hands-on experience engineering and directing for clients the remediation and commissioning of FDA-regulated and ISO quality systems.

She leads a team of quality system consultants, medical device consultants, and quality auditors who are highly experienced in their disciplines and known for delivering favorable results.

Education

  • M.S., Quality Assurance and Regulatory Affairs, Temple University School of Pharmacy, 2005
  • M.B.A. Foundations, Temple University Fox School of Business; 2003
  • B.A., English, Temple University, 2001

 

Certifications Attained

  • ASQ Certified Quality Auditor (CQA)
  • ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE)
  • PMI Project Management Professional (PMP)
  • ITIL v3 Foundations

 

Publications

  • How to Establish a Document Control System for Compliance with ISO 9001:2015, ISO 13485:2016 and FDA Regulations. Milwaukee: ASQ Quality Press, 2015.

 

Expertise

  • Deploy and remediate quality management systems to support global regulatory compliance requirements, third party certification/registration and organizational business process improvement.
  • Perform assessments (audits) of systems and data to assists customers with establishing system baselines and eliminating systemic deficiencies.
  • FDA form 483 response and consent decree compliance/remediation
  • Computerized system validation (GAMP 5 and FDA Guidance General Principals of Software Validation) and validation of multi-tenant software platforms for SaaS provisioning (including cloud services) supporting a vast array of customer-specific IT service delivery strategies and requirements.
  • Perform and oversee the major QMS departmental activities including Management Responsibility, Quality Record, CAPA, Training, Audit, Document Control, Record Management, Product Traceability and Disposition, Process and Computerized System Validation, Manufacturing Batch Record and Batch Release, and Medical Device Complaint Management.

 

Experience overview

  • DePuy-Synthes companies of Johnson & Johnson
    Global Quality Remediation Senior Project Manager/Consultant
  • Unisys Corporation
    Medical Device Quality Management System Development, Commissioning and Management Consultant
  • Nopras Technologies
    GMP Aseptic Liquid Manufacturing Quality Management Subject Matter Expert for the Quintiles Consulting/Hospira Project
  • CSC Government Health Services Division
    Medical Device Quality Management System Development, Commissioning and Management Consultant
  • CSC Government Health Services Division/Dynport Vaccine Company
    GCP/GMP Clinical Quality Assurance Oversight and Auditing
  • NuGEN Inc.
    Medical Device Quality System Deployment for ISO 13485:2003 registration
  • Shin Nippon Biomedical Laboratories
    GCP Quality System Deployment
  • Morphotek, Inc.
    GMP/GCP Quality System Deployment
  • Lexicon Pharmaceuticals
    GCP audit support for Phase III clinical trials
  • IHI Ionbond
    ISO 9001:2008 and ISO 13485:2013 Quality System Gap Assessment

 

Click here to request more information or call us at (410) 245-7237.

About Ticalion Quality Management Services
Ticalion provides expert quality system deployment and remediation services to meet requirements for FDA compliance and ISO registration.