Trail Stone Consulting

Welcome to Trail Stone Consulting LLC. We provide quality consulting services to a variety of industries.

We have extensive experience with Quality and Organizational Excellence. Specific experience with 21 CFR 820, ISO 13485, ISO 9001, and 21 CFR 1271.

Over 15 years of experience and expertise in the following areas: developing and improving departmental and inter-departmental processes, managing daily operations and projects, ensuring regulatory compliance, and managing personnel, all with the highest standards of professional integrity and customer service.

Trail Stone Consulting LLC can be reached at joanne@trailstoneconsultingllc.com

Our work has included diverse industries such as Human Cell and Tissue, Medical Device and Implantables. This includes both small start-up organizations and international companies.

Microbiological Assay Validations
Provided scientific support for assay validation for in-house testing and external studies. This included designing, executing and summarizing validation studies for microbiology assays, flow cytometry and other analytical lab assays.

CAPA Coordination
CAPA Coordination and subject matter experts for an international Medical Device company. Assessed CAPA systems and contributed to current CAPAs. Opened new CAPAs, assessed risks (FMEA) and developed solutions. Managed project timelines for CAPA owners. Maintained regulatory compliance and cGMPs.

FDA 483 Remediation Project
Technical contributors re-validating high-volume sterile production processes for an international Medical Device company. Project oversight consulting. Addressed an FDA 483 response to maintain compliance. Document review, gap and risk analysis, re-validation (authored protocols and reports,) technical writing and compliance coaching.