Protocol Development, Troubleshooting & Execution

• Factory Acceptance Testing (FAT)
• Site Acceptance Testing (SAT)
• Commissioning Plans
• Test Scripts
• Resolution of Deviations
• Documentation to be leveraged for Qualification
• Decommissioning

Consultation

• cGMP/GLP Regulatory & Compliance risk analysis
• cGMP/GLP System & Component impact analysis
• CAPA - Corrective Action/Preventive Action
• Evaluation & Implementation
• Change Management
• Interaction with regulatory/compliance group(s) to prepare for pre-approval inspections
• OSHA - Ergonomic evaluation of workspace