WHAT I DO...

I cultivate a full spectrum of GCP Quality Management Including GCP Quality System Development, GCP Auditing, GAP Analysis and Process Improvement

  • Quality Management Systems

    Develop and implement global quality management systems in alignment with individual company organization and culture.

  • GxP Process Mapping and Standard Operating Procedures

    Develop GxP inspection-ready standard operating procedure. Expert technical knowledge developing GCP-compliant SOPs, policies and controlled forms and templates

  • GAP Analyses

    Perform GAP assessments of current quality management systems and provide resolutions for continuous improvement for inspection readiness.

  • Training

    Provide GCP and inspection readiness training including industry trends and lessons learned.

  • Auditing

    Conduct GCP audits including:

    • Service provider qualification and for-cause audits
    • Company internal integrity audits

    Provide creative and proactive solutions for issue resolution and process improvements.

  • Project Management

    Develop and execute project management plans including realistic budget, resources and timelines.  Develop and maintain dashboards for addressing critical path items and adjusting plans to meet goals.