Designed and developed LO1 Tracker System and implemented for a French medical device company to track products through a
lean manufacturing process
Provided SME consulting for the complete reengineering of a major west coast medical device company CAPA system and
support for consent decree resolution
Managed manufacturing, labeling and packaging SOP Remediation for a major Pharma
Provided CSV methodology, CAPA support, remediation and validation planning, assessments, and recommendations on technical and
compliance solutions for a major international combination products manufacturer
Validated an ERP System for a dental implant medical device company
Managed the Therapeutic Database (TDB) software development and validation for a major Midwest pharma
Managed remediation team and provided SME support on a sNDA effort. Major contributor to remediation efforts and on time sNDA
submission for a major phama
Managed validation efforts for a global Documentum and Core Dossier based eSubmissions project for a major pharma and medical
device company
Managed the remediation of 21 CFR Part 11 Standard Operating Procedures for a major pharma R&D organization
