Codex validation Group presentation

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CODEX Validation Group is a consulting company with broad experience in the cGMP, compliance, automation, and validation for the Pharmaceutical, Biotechnology and Medical Device industries committed to follow the highest ethical standards as we work with our customers.

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Codex validation Group presentation

  1. 1. VALIDATIONwww.codexvalidationgroup.com ENGINEERING STAFFING
  2. 2. Company Foundations Codex Validation Group, Inc. was founded by two (2) professionals with over 12 years of experience (over 25 years combine) in the Professional Service field serving multiple satisfied clients. International experience in the cGMP Compliance, Automation and Validation for Pharmaceutical, Biotechnology, and Medical device industries. (Puerto Rico, USA “East and West Coast”, Europe, and Latin America. )
  3. 3. Company Root Our professionals are mind oriented to the service support with a high degree of understanding of the fast and critical phases that the majority of companies are confronting today. Professionals with experience working in high regulated environments such as consent decrees, inspections, remediation actions, and Audits as internal resource and/or third party auditors.
  4. 4. Mission OurMission is to become the leader in the Regulatory Compliance, Engineering and Technical Support Services, for the manufacturing challenges. We hold out our mission by creating a hands-on partnership with our customers and provide reliable and cost effective solutions.
  5. 5. Vision Our vision is to become a leaders as engineering and validation solution provider that optimize asset reliability, performance and regulatory compliance. To be recognized by our customers as the best engineering and validation support partner that helps them achieve their business goals consequently.
  6. 6. Codex Validation GroupOrganizational CHART Company Officers Human Resource Accounting ComplianceEngineering IT Validation
  7. 7. Company Highlights• Provides Engineering, and Regulatory Services• Employees with over 15 years in the industry with local offices at Puerto Rico.• Our Core Team have provide services in over 15 Pharmaceuticals Costumers (P.R., U.S.A. and Europe)• Process Engineering with Extensive Project Implementation and Integrated Automation Experience.• Knowledge in Pharmaceutical, Medical Device, Diagnostic and Biotechnology industries.
  8. 8. Services Experience, competence and dedication – our employees embody these. We offer a staff of talented individuals to fill your validation, compliance, and technical services needs. We will provide you with talent that fits your specific requirements. Our flexible team will work under your supervision assuring that your goals are successfully achieved. Validation Services Engineering Regulatory Resourcing
  9. 9. Technical Expertise RegulatoryCompliance/Validation  Regulatory Compliance Assessment  Validation Master Plans  Computer System Validation (SDLC)  System Criticality Assessment  Manufacturing and Packaging Equipments Qualification  Software Quality Assurance Program  Laboratory Equipment Qualification  Cleaning Validation  Manufacturing Process Validation  Packaging Process Validation  Process Validation
  10. 10. Technical Expertise RegulatoryCompliance/Validation (Continued)  Standard Operation Policies  Process Improvement and Operating Procedures Development  Virtual Process/Network Qualification
  11. 11. Automation QualificationExpertise in System Development Life Cycle (SDLC)Documents Preparation  Validation Master Plans  User Requirements  System Design Documents  Traceability Matrix  Functional Requirements  Vendor Qualification  Design Requirements Specifications  IQ/OQ/PQ Documents  Validation Reports
  12. 12. Automation QualificationExpertise in System Development Life Cycle (SDLC)Documents Preparation (Continued)  System Level Impact Assessment  Part 11 Assessments  Criticality Assessment  Validation Reports
  13. 13. Qualification ExpertiseComputer Qualification  SCADA  LIMS  PLCS  Maximo  Virtual Network  Batch  Remote Access  EBI  Servers Qualification  SAP  Network Qualification  MES
  14. 14. Qualification Expertise Utilities Qualification Water Systems Steam Systems Clean Steam Systems HVAC Systems Compress Air Systems Boilers Vacuum Systems Chilled Water System Air Handing Units (AHUs)
  15. 15. Qualification Expertise Purified Water system (Commissioning & Qualification) RO Vapor Compression CDI USP Loop System WFI Loop System Water Distillation System
  16. 16. Qualification Expertise Compressed Air System (Commissioning, & Qualification) Dryers (Refrigerant & Desiccant) Air Compressor Distribution System Clean Steam Process Air
  17. 17. Equipment Qualification Expertise (Solid Dosage Form & Parenteral) Lyophilized  Compressing Machines Filler  Coating Machines Stopper  Encapsulation Machines Autoclaves  Cream Tanks & Lines Fluid Bed Granulators and  CIP/SIP Skids Dryers  Dust Collectors Tablet Inspection Vision  Ovens System Dryers Blenders
  18. 18. Packaging Qualification Experience(Solid Dosage Form & Parenteral) Bottle Oriented Machine Filler Machine Capper Machine Labeler Machine Induction Cap sealer Machine Cartoner Machine Bundler Machine Outsert Placer Machine Retorquer Machine Pallitizer Machine Blister Machine Cavity Sealer Machines Shrink Wrap Machines
  19. 19. Packaging Equipment Experience(Cont.) Auto bagger Machines Label Printers Vision Inspection System Hand Held Bar Code Inspection Systems Foil Printers Industrial type PLC for packaging machines Vials Inspection Machine
  20. 20. Cleaning in Place Systems Experience Intermediate Bulk Containers Solution Tanks Fluid Bed Granulators and Dryer Compression Machines Encapsulation Machines Solutions Delivery Pumps Product Transfer Lines CIP
  21. 21. Project Management (Cont.)We Just Deliver! Our dynamic approach, with a clear idea ofthe manufacturing requirements, and results-oriented attitudeserve to prove the we are leaders in manufacturing/packagingproject management.We can do: Contract administration Document control Project controls delivery Project execution planning Scheduling
  22. 22. Project Management (Cont.)(Engineering Documentation)We Just Deliver! Our dynamic approach, with a clear idea ofthe manufacturing requirements, and results-oriented attitudeserve to prove the we are leaders in manufacturing/packagingproject management. We can do: Master Plans FAT SAT Job Plans Project execution planning Scheduling Start-up / Commissioning/Factory Acceptance Test, /Training
  23. 23. Computerized Maintenance Management Solution We can assess the facility to determine the appropriate Computerized Maintenance Management Solution.  Paperless Solutions  Part 11 Assessment  Backlog Management  Data Clean-up  Help Desk Evaluation
  24. 24. Regulatory Expertise FDA ISO OSHA ISPE KFDA European Medicine Agency (EMA)
  25. 25. What Strategy we use?Simple, we deliver! It’s about our people and theircommitment to go beyond expectations. First at all,ensure that we add value to our client day to dayoperation by an effective and fast solution.Provide cost effective strategies for a day to daysituation. Afford professionals with vast experience inthe required consulting area.
  26. 26. What is the Difference  At Codex Validation Group we work closely with client’s staff to satisfy each specific client requirements during the validation process. Our protocols include customized validation approaches and methodology with clearly defined pre-determined acceptance criteria. We offer fast documentation turnaround and can often schedule validation projects with short lead times.
  27. 27. Clear Benefits  Principle benefits include reduced cost and time to achieve a compliant system.  We use a integrated approach to commissioning and validation activities, ensuring at all times cGMP compliances.  We offer full validation cycle services associated with manufacturing projects as well as offer services to retrospectively validate existing manufacturing processes.  We can assist you with interpretation of regulations in determining the validation requirements; manage implementation of methodologies and prepare necessary reports.
  28. 28. Our strengths Services DifferenceOur People
  29. 29. CODEX
  30. 30. 787.549.8192/787.544.7509w.acevedo@codexvalidationgroup.com www.codexvalidationgroup.com

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