General Validation Presentation


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General Validation Presentation

  1. 2. <ul><li>Published safety program </li></ul><ul><li>Safety officer is Principal of firm </li></ul><ul><li>Conformance to client standards </li></ul>Safety
  2. 3. <ul><li>Our Mission </li></ul><ul><li>We deliver services and products that enable our clients to achieve a higher level of success </li></ul><ul><li>Our Goals </li></ul><ul><li>Maximize your benefits and minimize the costs of complying with current Good Manufacturing Practices (cGMP) </li></ul><ul><li>Provide quality services allowing clients to deliver their products to market faster </li></ul><ul><li>Utilize innovation and technology to maximize efficiency and effectiveness </li></ul>
  3. 4. MD Employees 10 MD Consultants 12 PA Employees 7 PA Consultants 2 MA Employees 1 MA Consultants 2 Administration 4 Total Staff 38
  4. 5. “ What we need to do is learn to work in the system, by which I mean that everybody, every team, every platform, every division, every component is there not for individual competitive profit or recognition, but for contribution to the system as a whole on a win-win basis” -W. Edwards Deming
  5. 6. Owner Validation, Inc. Project Team
  6. 7. <ul><li>Principal involvement & commitment </li></ul><ul><li>Effective evaluation of alternatives and investigative solutions </li></ul><ul><li>Project management involvement from detail design to Process Validation </li></ul><ul><li>Sensitivity for existing operations </li></ul><ul><li>Understanding Client Standards </li></ul><ul><li>Responsive and cost conscious </li></ul><ul><li>Proactive </li></ul>The Validation, Inc Difference
  7. 8. <ul><li>Establish and maintain long term relationships with our clients based on trust, integrity and accountability </li></ul><ul><li>This commitment has resulted in repeat business of >90% with our valued clients </li></ul>The Validation, Inc Culture
  8. 9. <ul><li>Scheduled kick-off meeting </li></ul><ul><li>Effective communication </li></ul><ul><li>Project scheduling </li></ul><ul><li>Resource management </li></ul><ul><li>Project controls </li></ul><ul><li>Weekly status reports </li></ul>Project Management
  9. 10. Our
  10. 11. SERVICES Our <ul><li>Detail Design Review </li></ul><ul><li>Commissioning </li></ul><ul><li>Calibration/Maintenance Management </li></ul><ul><li>Equipment Qualification </li></ul><ul><li>Process Validation </li></ul><ul><li>Cleaning Validation </li></ul><ul><li>Computer System Validation </li></ul><ul><li>Analytical Instrument Qualification </li></ul><ul><li>Analytical Assay Development </li></ul><ul><li>PAI Readiness </li></ul>Services
  11. 12. <ul><li>We provide commissioning documents that result in a complete Engineering Turn-over Package (ETOP) that is considered the point of delivery into the qualification effort. </li></ul><ul><li>Leverage commissioning knowledge to accelerate the qualification process </li></ul><ul><li>Develop and execute commissioning plans </li></ul><ul><li>Develop commissioning documents (e.g. User Requirement Specification, inspection forms, Factory Acceptance Tests and Site Acceptance Tests) </li></ul><ul><li>Witness vendor commissioning activities </li></ul><ul><li>Manage the commissioning activities of vendors, contractors, and system owners </li></ul>Commissioning and Start-Up
  12. 13. <ul><li>Calibration Program Review </li></ul><ul><li>Proactive deviation reduction </li></ul><ul><ul><li>Process tolerance review </li></ul></ul><ul><ul><li>Actual vs. validated vs. calibrated </li></ul></ul><ul><li>Deviation investigation and resolution </li></ul><ul><li>Shutdown coordination </li></ul>Calibration/Maintenance Management
  13. 14. <ul><li>We have the experience to validate most manufacturing equipment or supporting utility system. </li></ul><ul><li>Validation Master Plans </li></ul><ul><li>Leverage commissioning information into IQ/OQ </li></ul><ul><li>Installation Qualifications </li></ul><ul><li>Standard Operating Procedures (SOPs) </li></ul><ul><li>Operational Qualifications </li></ul><ul><li>Performance Qualifications </li></ul><ul><li>Final Reports </li></ul>Equipment Qualification
  14. 15. <ul><li>Fit-For-Use Approach to Verification – Key Elements </li></ul><ul><li>Identification of risks with respect to patient risk </li></ul><ul><li>Appropriate level of verification given the risk </li></ul><ul><li>Focus on important issues with approved documents </li></ul><ul><li>Critical Quality Attributes </li></ul><ul><li>Critical Process Parameters </li></ul>ASTM E-2500
  15. 16. <ul><li>Focused efforts up front in process to diminish downstream work </li></ul><ul><li>Good Engineering Practices </li></ul><ul><li>Vendor support documents </li></ul><ul><li>Identify Subject Matter Experts to support project </li></ul><ul><li>Summarize process for each system and prepare written justification </li></ul><ul><li>Eliminate redundant testing </li></ul>ASTM E-2500
  16. 17. <ul><li>Our validation consultants have experience validating processes in all disciplines of the FDA regulated industries. </li></ul><ul><li>Review development reports to determine the critical processing steps and quality attributes </li></ul><ul><li>Develop scientifically justified validation plans, which demonstrate consistency and reliability in processing </li></ul><ul><li>Assist in developing statistically justified in-process and finished product sampling strategies. </li></ul>Process Validation
  17. 18. <ul><li>We have the expertise to guide you through the Cleaning Validation process. </li></ul><ul><li>Establish a Cleaning Master Plan </li></ul><ul><li>Set residual acceptance criteria </li></ul><ul><li>Prepare a comprehensive sampling plan </li></ul><ul><li>Validate and use appropriate analytical methods </li></ul>Cleaning Validation
  18. 19. <ul><li>We provide training programs to meet our specific customers' needs by pulling from our extensive knowledge base of compliance, quality systems and validation. </li></ul><ul><li>Our Training Programs: </li></ul><ul><li>Compliance with Current Regulations </li></ul><ul><li>GAMP 5 </li></ul><ul><li>Establishing Quality Systems for System Development Life Cycle Management </li></ul><ul><li>Good Documentation Practices </li></ul>Training
  19. 20. <ul><li>Our approach includes an audit against internal practices and GxP Regulations. </li></ul><ul><li>Identify all systems that fall under GxP regulation </li></ul><ul><li>Conduct gap analysis </li></ul><ul><li>Develop a risk analysis for each system </li></ul><ul><li>Prioritize the systems based upon the risk analysis </li></ul><ul><li>Develop an action plan to address non-compliance </li></ul><ul><li>Schedule and execute the action plan </li></ul>Compliance/PAI Readiness
  20. 21. <ul><li>ISPE </li></ul><ul><ul><li>Chesapeake Bay – Board of Directors </li></ul></ul><ul><ul><li>Delaware Valley </li></ul></ul><ul><ul><li>New Jersey </li></ul></ul><ul><li>PDA </li></ul><ul><li>ASQ </li></ul><ul><li>PMI </li></ul>Associations
  21. 22. <ul><li>Genesis Engineers, Inc. – MEP Engineering </li></ul><ul><li>MicroBiological Environments – Lab Analysis </li></ul><ul><li>ENV – Calibration and Certification </li></ul><ul><li>DCI – Vessel/CIP System Manufacture </li></ul>Strategic Alliances
  22. 23. <ul><li>What are your current needs? </li></ul><ul><li>Process </li></ul><ul><li>Utilities </li></ul><ul><li>Analytical </li></ul><ul><li>Calibration Management </li></ul>
  23. 24. ? ? ?