Engineering
- Facilities Design
- Aseptic Clean Room Design
- Process Flow Design (Personnel, Equipment, Material, and Waste)
- Facility Capacity Modeling
- Lean Six Sigma Manufacturing Process Improvement
- Micro & Analytical Lab Design
Project Management
- Project Feasibility
- Scope of Work Development
- Conceptual Development
- Project Delivery/Planning
- Project Design
- Project Implementation
- Project/Financial Closeout
Validation & Qualification
- Validation Master Plan Development
- Facility Qualification
- Equipment Qualification / Validation
- User Requirements Specification (URS)
- Factory Acceptance Testing (FAT) Protocol Generation
- Site Acceptance Testing (SAT) Protocol Generation
- Initial & Operational Qualification (IQOQ) Protocol Generation
- Performance Qualification (PQ)Protocol Generation
- Process Validation
- Computer Systems Validation (CSV)
Maintenance & Calibration
- Development of Computerized Maintenance Management System (CMMS)
- Development of Preventive Maintenance Program
- Development of Reliability Centered Maintenance (RCM) Program
- Development of Total Predictive Maintenance (TPM) Program
- Development of Calibration Program
- Development of Computerized Calibration Management System (CCMS)
- Procedure Development
Regulatory & Compliance
- Quality Systems Development & Audits (Documentation Control, Training, Change Control, & Deviation Management)
- FDA Readiness Audit
- FDA Pre-Approval Inspection (PAI)
- Facility Inspections
- Investigations
- Corrective Actions
- Preventive Actions
- Root Cause Analysis
- Remediation and Action Plan Development