BCS Organizational Chart
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1 BE&K Validation
2 BCS Organizational Chart Business Development Mgr. Dwight Rivera President Accountant QA and Compliance Technical Services Engineering / Manufacturing Packaging and Inspection Sr. QA Sr. Validation Project Manager Sr. Vision Engineer QA Sr. Validation Project Engineer Vision Engineer Sr. Validation Sr. Validation Project Engineer Packaging Engineer Sr. Validation Sr. Validation Validation Validation Validation
3 CORE COMPETENCIES Strengths Experience Vast experience with 483s, Warning letters and Consent Decree Project Management Experience in ALL aspects of Validation International Experience (EU, MCA, Japan, etc.) Operating Experience Current with the latest FDA directives Contract Manufacturers Finished Pharmaceuticals API Production Biopharmaceutical Production Inspection of Drug Product Containers Medical Devices Secondary Packaging
4 Process Technology Expertise Biotechnology Bulk Pharma/ API Formulation Fill/Finish Materials Handling Media Preparation Fermentation Buffer Preparation Organic Synthesis Hydrogenation DCS/PLC Controls CIP/COP/SIP Raw Materials Storage/Handling Raw Materials Handling Blending & Mixing Tableting Encapsulation Powder Granulation Nasal Gels Aerosols Ointments & Lotions Topicals Packaging Warehousing Separation WFI/USP/RO/DI Water Opthalmics Laboratories Purification Mixing/Blending Parenterals Clean Utilities Lyophilization Chromatography Gel Filtration Filling Waste Handling CIP/COP/SIP Heat Exchangers Clean Rooms Sterile Rooms Clean Utilities Pre-filled syringes Galenicals Liquids Transdermals Manual Inspection Semi-auto Inspection Barrier Isolation Technology Sterile Filling Continuous Sterilization Serialization Clean Utilities Automatic Inspection
5 ENGINEERING SERVICES OFFERED Architectural Site/Facility Master Planning Process Flows Product, Personnel, Waste and Material Flow Room Adjacencies Programming cglp and cgmp compliance HVAC Application of cgmp Regulations Clean Room Design Design of Aseptic/Sterile areas Mechanical Clean Steam Generation and Distribution Systems DI and Purified Water Systems Fixed and Portable CIP/SIP Systems Hot / Cold WFI Distribution and Storage Systems Clean Air & Laboratory Gas Systems Waste Treatment Systems Autoclaves
6 COMPLIANCE SERVICES OFFERED Design Review FMEA / ASTM 2500 Consulting SQAP preparation GMP Audits Validation Master Planning Commissioning (Prepare and Execute) Validation Protocols Vendor/Supplier Audits Reliability Engineering Quality Event Investigation SOP Preparation/Review GMP Training Regulatory Affairs Consulting Visual Inspection Process Development / Training Knapp Studies Alternate Processes (Manual, Auto and Semi-automated)
7 BCS Integrated Approach PROTOCOL DRAFT DEVELOPMENT & FAT CRITERIA 1st REQUEST FOR COMMISSIONING MECHANICAL COMPLETION UTILITIES START-UP FACILITY READY FOR START-UP PROCESS START-UP QA/QC FACILITY APPROVAL FINAL AGENCY ACCEPTANCE LIFE CYCLE COLLECTIVE COMMISSIONING & VALIDATION MANAGEMENT ENGINEERING CONSTRUCTION STARTUP OPERATION PROTOCOLS CCV NON CRITICAL SYSTEMS CCV SCHEDULING CCV CRITICAL SYSTEMS FAT / SAT UTILITIES STARTUP PROCESS STARTUP TIME
8 TEAM MEMBER RECENT CLIENTS Hospira NC Sandoz NC Organon Teknika NC Bristol-Myers Squibb PR Becton Dickinson NC Janssen - PR Fleet Labs - VA Watson Laboratories CA Pfizer PR Bausch & Lomb FL Boston Scientific - PR Ortho Biologics - PR Amgen PR
9 ALLIANCES Machines Manufacturer for: Packaging Medical Device Syringe Assembly Safety Devices Specialized Automated Applications Visual Inspection Applications Robotics Applications Turn Key Solutions CAPA Six Sigma
10 Guaranteed lead time of 6 months for all your packaging needs.
11
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13 Contact Phones (787) / (787) Mail PO Box 217 Manati, PR info@biopharma-pr.com
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