Effective medical device validation introduction manual advance


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Effective medical device validation introduction manual advance

  1. 1. Welcome to this short introduction to the contents of the presentation on Effective Medical Device Validation http://www.PresentationEze.com This presentation provides information on • the contents of the Presentation – Section A (Pgs 2 – 23) • ordering, cost & product delivery details – Section B (Pgs 24 – 26)
  2. 2. Section A (i) – Medical Device Validation <ul><li>Summary of product contents: </li></ul><ul><li>Introduction </li></ul><ul><li>Regulatory Requirements & International Standards </li></ul><ul><li>Medical Devices </li></ul><ul><li>Approach to Process Validations </li></ul><ul><li>Approach to Software Validation </li></ul><ul><li>Design Control : Design Input & Design Output </li></ul><ul><li>Lifecycle Approach to Validation </li></ul><ul><li>- inc. Qualifications (IQ, OQ, PVS, PQ) </li></ul><ul><li>Documentation expectations </li></ul><ul><li>Approach to revalidation </li></ul><ul><li>The Validation Master Plan (VMP) </li></ul><ul><li>Process Validation Gap Analysis </li></ul><ul><li>Risk Based Approach to Validation Planning </li></ul><ul><li>Other Validations </li></ul><ul><li>Protocol Reporting </li></ul><ul><li>Auditing </li></ul><ul><li>When is a process Validated ? </li></ul><ul><li>Review of sample FDA warning letters. </li></ul><ul><li>References </li></ul>
  3. 3. Section A (ii) – Creating Compliant Validations <ul><li>Quality Tools and Statistics </li></ul><ul><ul><li>Quality Improvement Techniques </li></ul></ul><ul><ul><li>Statistical Techniques </li></ul></ul>
  4. 4. Introduction <ul><li>Why perform Product Validations? Regulatory (FDA, EU. etc.), Customers, </li></ul><ul><li>Business expectations, etc. </li></ul><ul><li>Effort versus Risk. Risk and Process Validation. </li></ul><ul><li>Integration of Validation and Risk into the product life cycle, integration into the </li></ul><ul><li>Quality Management System. </li></ul><ul><li>Validation versus Verification. </li></ul><ul><li>Definitions related to Validation. </li></ul>
  5. 5. Regulatory Requirements and International Standards <ul><li>FDA QSR (Quality System Requirements) and Process Validations. </li></ul><ul><li>21CFR 211, 21CFR 820. – pre-market assessment, risk minimisation, Part 11. </li></ul><ul><li>ISO 13485:2003 expectations; ISO 14971:2009 – expectations </li></ul><ul><li>Regulatory body expectation summary. </li></ul><ul><li>The FDA’s Draft Process Validation Guidance * </li></ul><ul><li>Key changes between the 1987 Process Validation Guidance and the 2008 FDA Draft. </li></ul><ul><li>Comparison between FDA 2008 Draft on Process Validation and ASTM E2500. </li></ul><ul><ul><li>Impact on Design and Verification </li></ul></ul><ul><li>* While the 2008 Draft is not specifically mentioned by the CDRH, it does represent the latest in FDA thinking on Process Validation </li></ul>
  6. 6. Medical Devices <ul><li>Definition </li></ul><ul><li>Types of devices per the Medical Device Directives. </li></ul><ul><li>Classification </li></ul><ul><li>Classification rules </li></ul><ul><li>Risk Assessment </li></ul>
  7. 7. Approaches to Process Validation <ul><li>QSIT Guide & Focus. </li></ul><ul><li>Focus on Production & Process Controls. (P&PC) </li></ul><ul><li>P&PC – Objectives, Importance, </li></ul><ul><li>When to Validate a Process. </li></ul><ul><li>Examples of processes that should be Validated. </li></ul><ul><li>Examples of processes that may be Verified. </li></ul><ul><li>How do I know if a process cannot be fully Verified? </li></ul>
  8. 8. Approach to Software Validation <ul><li>Guidance for Software Validations </li></ul><ul><li>- GAMP Guide (Good Automated Practices) </li></ul><ul><li>Categories of Software </li></ul><ul><li>Software Life Cycle </li></ul><ul><ul><li>User Requirements Specification </li></ul></ul><ul><ul><li>Functional Specification </li></ul></ul><ul><ul><li>Hardware Design Specification </li></ul></ul><ul><ul><li>Software Design Specification </li></ul></ul><ul><ul><li>Software Module Design Specification </li></ul></ul><ul><ul><li>Application Software Production </li></ul></ul><ul><ul><li>Module Software Test Specification </li></ul></ul><ul><ul><li>Integration Test Specification </li></ul></ul><ul><ul><li>Acceptance Test Specification </li></ul></ul><ul><ul><li>Verification Requirements & Design Specification </li></ul></ul><ul><ul><li>Verifying Test Steps, Expected Outputs and Evaluation Criteria </li></ul></ul><ul><li>Computer System Validation </li></ul><ul><li>Electronic Records and Electronic Signatures </li></ul><ul><li>Closed Software Systems, Audit Trail Requirements </li></ul><ul><li>Extent of software validation to be performed </li></ul>
  9. 9. Design Control: Design Input & Design Output. <ul><li>New Quality System Requirements for Design Controls </li></ul><ul><li>Design Input & Output, Expectations, Regulations & Examples </li></ul><ul><li>Rationale for new Design Control Requirements </li></ul><ul><li>The Process of Design Control </li></ul><ul><li>Design and Development Planning </li></ul><ul><li>Design Input Types, sources, considerations, etc.. </li></ul><ul><li>Design Output Expectations </li></ul><ul><li>Design Reviews </li></ul><ul><li>Verification and Validation </li></ul><ul><li>Design History File </li></ul>
  10. 10. Life Cycle Approach to Validation <ul><li>Benefits of a Life Cycle Approach </li></ul><ul><li>Functional Requirements </li></ul><ul><li>System Specifications </li></ul><ul><li>Installation Qualification (I.Q.) </li></ul><ul><li>GHIT Guide, 820.70 requirements </li></ul><ul><li>Test types to be performed </li></ul><ul><li>Example test details </li></ul>
  11. 11. Life Cycle Approach to Validation continued. <ul><li>Operation Qualification (O.Q.) </li></ul><ul><li>GHIT Guide, 820.70 requirements </li></ul><ul><li>Test types to be performed </li></ul><ul><li>Example test details </li></ul><ul><li>Pre-Validation Study (PVS) </li></ul><ul><li>Definition </li></ul><ul><li>Tests (example) to be performed </li></ul><ul><li>Performance Qualification (P.Q.) </li></ul><ul><li>Definition </li></ul><ul><li>Tests (example) to be performed </li></ul><ul><li>Re-Qualification </li></ul><ul><li>Change Control </li></ul><ul><li>Quality Trending </li></ul>
  12. 12. Documentation <ul><li>Documenting routine production </li></ul><ul><li>Where to keep documentation </li></ul>
  13. 13. Revalidation <ul><li>Revalidation and changes </li></ul><ul><li>Review and Evaluation of Revalidation </li></ul><ul><li>Significance of “where appropriate” in revalidation </li></ul>
  14. 14. Master Validation Plan (VMP) <ul><li>VMP development process </li></ul><ul><li>Why, Who, How, When & What. </li></ul><ul><li>Definition </li></ul><ul><li>Why is a VMP necessary? </li></ul><ul><li>Who prepares and approves the plan? </li></ul><ul><li>How do you prepare & assemble a plan? </li></ul><ul><li>Elements of a Validation Master Plan. </li></ul><ul><li>Post Validation project program descriptions. </li></ul><ul><li>Calibration </li></ul><ul><li>Preventative Maintenance </li></ul><ul><li>Training </li></ul><ul><li>Change Control </li></ul><ul><li>Document Control </li></ul><ul><li>Re-qualification </li></ul><ul><li>Implementation of the VMP </li></ul><ul><li>Documenting the closure </li></ul>
  15. 15. Validation Gap Analysis <ul><li>The role of gap analysis </li></ul><ul><li>How to plan and develop a gap analysis to assess compliance </li></ul><ul><li>Typical assessment Tools and Techniques </li></ul><ul><li>Determining the methodology to use </li></ul><ul><li>Preparing for issues that may be found </li></ul><ul><li>Applying risk-based remediation </li></ul><ul><li>Recording observations and addressing problem areas </li></ul>
  16. 16. Risk Based Approach to Validation Planning <ul><li>Why use a risk based approach? </li></ul><ul><li>What are the various risk assessment models, e.g. ENISO 14971 </li></ul><ul><li>What are the various Risk Assessment Tools and Techniques </li></ul><ul><li>Scope and Problem determination. </li></ul><ul><li>Severity, Probability and Detect-ability </li></ul><ul><li>Advantages / disadvantages, examples, where to apply. </li></ul>
  17. 17. Other Validations <ul><li>Fixture Qualification </li></ul><ul><li>Definition </li></ul><ul><li>Tests to be performed </li></ul><ul><li>Component/material qualification </li></ul><ul><li>Definition </li></ul><ul><li>Content of procedure section </li></ul>
  18. 18. Protocol Reporting <ul><li>Definition </li></ul><ul><li>Qualification Report Content </li></ul><ul><li>Protocol Report summary </li></ul><ul><li>Data Analysis Summary </li></ul><ul><li>Exception statement </li></ul>
  19. 19. Auditing <ul><li>Approaches to Auditing a Validation Program </li></ul><ul><li>Developing the audit terms of reference </li></ul><ul><li>Scope and approach to the audit </li></ul><ul><li>Auditing techniques </li></ul><ul><li>Conducting a risk assessment of audit observations </li></ul>
  20. 20. When is a Process Considered Validated <ul><li>Bringing all the elements together </li></ul><ul><li>People requirements, e.g. training, independence,.. etc. </li></ul><ul><li>Forward planning requirements </li></ul>
  21. 21. Example FDA related warning letters <ul><li>  </li></ul><ul><li>Review of example Warning Letters issued by the FDA for validation deviations </li></ul><ul><li>Common root causes for validation deficiencies </li></ul>
  22. 22. Creating compliant Validations – Quality Tools and Statistics Quality Improvement Techniques <ul><li>Quality Improvement process </li></ul><ul><ul><li>Define, Analyse, Root Cause, Solve, Monitor. </li></ul></ul><ul><li>Brainstorming </li></ul><ul><li>Process Flow charts </li></ul><ul><ul><li>Creating a Flowchart, Analysis </li></ul></ul><ul><li>Pareto charts </li></ul><ul><ul><li>Steps to construct, </li></ul></ul><ul><li>Cause & Effect Diagrams </li></ul><ul><ul><li>Why use, how to use. </li></ul></ul>
  23. 23. Creating compliant Validations – Quality Tools and Statistics Statistical Techniques <ul><li>Introduction to Statistics/Histograms </li></ul><ul><ul><li>Mean, Mode, Range, Variance, Standard Deviation, how to construct Histograms, Normality. </li></ul></ul><ul><li>Variable Control Charts </li></ul><ul><ul><li>X-Bar, R-Charts, Control Limits, Trends, Cause of out of control limits, Corrective Action. </li></ul></ul><ul><li>Gauge repeatability and reproducibility (R+R Studies) </li></ul><ul><ul><li>Gauge selection, why perform, when to perform, benefits. </li></ul></ul><ul><li>Capability analysis </li></ul><ul><ul><li>Advantages. Types. Cp, Cpk. Interpretation. </li></ul></ul><ul><li>DPU charts </li></ul><ul><ul><li>Constructing DPU charts. </li></ul></ul><ul><li>Cycle time analysis </li></ul>
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