Data analytics, auditing, audit hosting, validation and staff management. Identification, remediation and implementation of quality improvements and inspection preparation. Analytical chemist, cGXP, quality systems and procedures. Equipment, Process and IT/ Software/ Interface / CSA/ CA Validation, FDA Regulations, Quality Regulation Systems, European EU Requirements and ISO 13485: 2016, ISO 19011:2018, ISO 11737-1-2018, ISO 11135, ISO 14971. CAPA Management, Deviation Investigations, Deviation Investigations, Facilities Compliance, Metrology / Calibration SME, Adverse Event Management, Validation Engineering, Project Manager, Instrumentation, Change Controls, Laboratory Management, QMS SOP Writing and revision (editing). FDA QSR, QMSR, CFR Documentation, Water Management Plans, Legionnaires Prevention, Building Compliance, Chemistry Laboratory Building Construction Commissioning and Qualification, Pharmaceutical Production Facility Construction Commissioning and Qualification Consulting.
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