SEPTEMBER - 20217TECH OUTLOOK "Where Quality Matters" SERVICES Project Management · Project Feasibility, Scope of Work Development, Conceptual Development, Project Delivery/Planning, Project Design, Project Implementation, Project Financial Closeout Engineering · Facilities & Manufacturing Design, Aseptic Clean Room Design, Process Flow Design (Personnel, Equipment, Material and Waste), Laboratory Design. · Facility Capacity Modeling, Lean Six Sigma Manufacturing Process Improvement 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 · Protocol Generation Qualification (IQOQ) & Performance Qualification (PQ), and Computer Systems Validation (CSV) Regulatory & Compliance · Quality Systems Development & Audits · FDA Readiness Audits & FDA Pre-Approval Inspection (PAI) · Facility Inspections · Investigations (Corrective Actions, Preventive Actions, Root Cause Analysis) · Remediation and Action Plan Development 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) · Technical Writing & Procedure Development MISSION We are a Veteran Owned & Operated Company. Our Mission is to provide our customers with affordable and reliable solutions for their Engineering, Project Management and Regulatory needs. We do this by identifying innovated technology solutions, appropriate resources, and processes, delivering quality systems that meets FDA & EU regulatory requirements. Thus, ensuring the quality and safety of all products while maximizing capital investments. CONTACT US MONDAY-FRIDAY 8:00AM-5:00PM EST PHONE: 610-842-4445 EMAIL: INFO@FIRSTPHARMCONSULTANTS.COM WEBSITE: WWW.FIRSTPHARMACONSULTANTS.COM
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