Validation Program Design


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A powerpoint presentation outlining Arc Engineering’s design philosophy for implementing/auditing a validation program.

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Validation Program Design

  1. 1. Process Validation Assessment/Implementation Project<br />Moog, Terumo & Arc Engineering<br />February 9, 2011<br />
  2. 2. Process Validation Overview & Objective<br />Regulations, Guidance & Internal Controls<br />Validation Lifecycle Approach & Risk Based Model<br />QUEST - Five Step Method to Process Validation<br />Question<br />Understand <br />Evaluate<br />Site Assessment/Implementation<br />Track<br />Basecamp Website<br />Conclusion<br />
  3. 3. Process Validation <br />Regulatory Requirements<br />21 CFR 820 – Medical Device Quality System Regulation <br />Design Validation (820.30)<br />Process Validation (820.75)<br />Inspection Measurement & Test Equipment/Calibration (820.72)<br />Supporting Requirements (i.e. 820.40: Document Control)<br />Guidance Documents<br />ISO 13485 – International Standard for Medical Device QMS’s<br />GHTF SG3 - Process Validation, Risk Management Guidance<br />Internal Documents (Moog & Terumo)<br />Design History File (Who owns design validation and DFMEAs?)<br />Industry Standards for Sensors?<br />Control Plans, Job Travelers and PFMEAs<br />Terumo specification documents or drawings?<br />
  4. 4. Regulatory Requirements<br />Design Validation Requirements (820.30)<br />Demonstrates a process is operating within specified limits and consistently produces product complying with predetermined requirements<br />Process Validation Requirements (820.75)<br />Process monitoring & control<br />Change Control & Deviation Management Systems <br />Vitally important if the predetermined requirements of the product can only be assured by destructive testing<br />So… what does this mean for device manufacturers?<br />
  5. 5. How is Compliance Demonstrated? <br />Ask yourself the following questions…<br />Have your processes been subject to such scrutiny that the result can be practically guaranteed? <br />Do you have confidence in your manufacturing processes?<br />Do you have scientific evidence that your processes are capable of consistently delivering quality product?<br />Have you demonstrated the process works as intended?<br />Key Point: Documented evidence of process capability is critical <br />
  6. 6. Validation Lifecycle Approach<br />Monitoring Elements <br />Design Elements <br /><ul><li> Change Control
  7. 7. Calibration
  8. 8. Process/Statistical Data
  9. 9. Training
  10. 10. Maintenance
  11. 11. Periodic Review
  12. 12. CAPA
  13. 13. Requirements
  14. 14. Specifications
  15. 15. Impact Assessments
  16. 16. Risk Assessments
  17. 17. Drawings</li></ul>Validation Master Plan <br />Often used to define specifically how the Validation Lifecycle will be managed and contains specific process and equipment validation tracking information. <br />Confirmation Elements <br /><ul><li> Design Validation (DV)
  18. 18. Equipment Validation (IQ/OQ)
  19. 19. Process Validation (PQ/PV)</li></li></ul><li>Risk Based Validation Process Model<br />Product Knowledge<br />Engineering Policies and Practices<br />Process Knowledge<br />Regulatory Requirements<br />Risk Management<br />Company Quality Regs.<br />Design Review<br />Change Control<br />Diagram courtesy of ASTM<br />
  20. 20. Moog Process Validation Discussion<br />Site Audit Review from August 2010… <br />Discuss Process Validation Related Observations/Findings<br />Associated CAPA<br />QUEST Process<br />Question<br />Survey - (Completed)<br />Kick-off meeting, initial walk-through & subsequent on-site visits<br />Understand<br />Supplier processes and industry specific standards<br />Requirements and specifications (Acceptance Criteria)<br />Risk assessment processes & process controls<br />Product expectations from both Moog & Terumo <br />
  21. 21. Moog Process Validation Discussion<br />QUEST Process… continued<br />Evaluate<br />Existing process validation elements employed by Moog<br />Opportunities to improve process control & eliminate variation <br />Addition of PV elements to existing QMS:<br />Considerations: Cost, time, organizational maturity, culture & regulations<br />The only things not “negotiable” are the program's objectives:<br />System meets process requirements <br />Risks to patients are adequately controlled <br />Documented evidence of system controls are available<br />
  22. 22. Moog Process Validation Discussion<br />QUEST Process… continued<br />Site Assessment/Implementation<br />Strategy & effort commensurate with the complexity and needs of the existing system<br />Complex <br />Multiple phase, continuous improvement approach to implementation<br />“Rome wasn’t built in a day.” <br />Validation Master Plan with equipment/process list & schedule<br />Equipment Validation IQ/OQ Protocols & Reports <br />Initial focus on ‘Direct Impact Equipment’<br />Process Validation Plans, Protocols & Reports <br />Focus on critical quality attributes & critical process parameters<br />Subsequent phases implement complementary systems including; <br />Impact/risk assessment, maintenance, calibration, change control, document control/retention, training, periodic review & CAPA systems<br />Simplistic <br />Assessment & report for fully functioning Process Validation systems<br />
  23. 23. Moog Process Validation Discussion<br />QUEST Process… continued<br />Track<br />Remember, Process Validation is a continuous cycle…<br />Process Monitoring & Continuous Improvement activities include;<br />Change Control <br />CAPA Tracking & Trending <br />Use of statistical software for objective process monitoring  <br />Management review & evaluation equipment/instrument upgrades  <br />Periodic review of qualification status <br />Revalidation if applicable <br />Customer audits verify system suitability<br />
  24. 24. Basecamp Website<br />Basecamp offers:<br />Project communication, messages, contacts, writeboards<br />Planning and status tracking with to-do lists and milestones<br />File sharing and storage<br />Security and customizable permissions<br />Benefits:<br />Centralized, easily accessible, well documented, secure project records<br />
  25. 25. Conclusion<br />Recap/Discussion/Questions<br />Arc Engineering is always available and pleased to assist further, to provide insight and resolve any uncertainties!<br />We look forward to a productive and mutually beneficial experience for Terumo and Moog!<br />