Consulting Services for clients requiring Quality, Regulatory Compliance, Disparity Studies, Analytical Studies, Translation and Interpreting Services. Scientific technical writer with 23 years of experience in medical device, pharmaceutical and biopharmaceutical compliance and 19+ of quality management. Experience providing industry and government entities: Water Management Plans, Legionnaires Prevention, Building Compliance, Chemistry Laboratory Building Construction Commissioning and Qualification, Pharmaceutical Production Facility Construction Commissioning and Qualification Consulting. All services and training are available in Spanish and English.
Additional:
UDI /GUIDID Labeling Compliance FDA Inspection Host / Management Representative
QSR to QMSR transition and implementation
QMS SOP Writing and revision (editing).
ISO 11737-1-2018 ISO 11135 ISO 14971 ISO 19011:2018,
Risk Mgt ISO 14971
21 CFR 820 and Part 4
21 CFR Part 11
CFR Documentation
Gap Assessment
Statistical Analysis
FDA QSR, QMSR
Laboratory Management
Change Controls Project Manager Validation Engineer Adverse Event Management
Metrology / Calibration SME Facilities Compliance Deviation Investigations Remediation Projects
CAPA Management CAPA Training inspection preparation Continual improvement
IT/ Software/ Interface / CSA/ CA Validation Process Validations
Cleaning Validations Sterilization Validations ISO 13485: 2016 Annex 11