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LO1 Tracker

Typical Engagements

Industry Related Experience

Program/Project Management

Qualified Resources






Typical Engagements

  • 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

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