Ceo
Current• GMP, GLP, ICH & GCP Auditing Services - Manufacturing, Research & Development, Clinical, Medical, Laboratories - Contract Manufacturer’s, Vendors & Suppliers - Bio-Pharma OTC, Ethical, Nutraceuticals, Chemical, Bulk API - Mock FDA, WHO, and EMEA Audits• Validation (Process, Facility & Equipment) Auditing Services - EDC, MRP, MMCS, LIMS, SCADA, PLC, DCS, Custom and COTS applications - Process Equipment, Manufacturing, Utilities, Engineering• Auditing and development of validation master plans for Computer Systems and Software including but not limited to: - SDLC, VMP, VPD development, user requirements and functional requirements - Design qualifications, including schemas, flow diagrams and data modeling - Installation qualifications, gap analysis, and component inventories - Operational qualifications, test script development, training and executions - Performance qualifications• Auditor of 21 CFR Part 11 Remediation & Computer Systems Validation• Audits of Process, Manufacturing, and Analytical Equipment, LIMs, EDC, Clinical Data Management, SAE, AER, PLC, SCADA, etc.• Engineering (Design / Build Facility Audits), Software Programming and Code Management Audits, Maintenance and Technical Compliance Audits• ‘For-Cause’ and Due-Diligence Audits• Vendor and Supplier Qualification Audits• FDA Assisted Audits, Pre-FDA Inspection Audits and Clinical Trial Audits• Employee / Investigator Audits and Investigations (CV Audits)• Conduct GMP, QSR, Part 11 Electronic Systems, GLP and GCP Training Seminars
