Presentation Fundamentals of V&V
- 1. 8:30AM Rommel B. Garcia Consultant Project Manager Email: melmaan2010@gmail.com
- 2. Best Practices in making sure that verification and validation documentations are well understood Rommel B. Garcia Consultant Project Manager
- 3. So you think you are intelligent and you think you are right! Well, guess what, someone else think that you are wrong! Mr. OPinion
- 4. A company in the past thru a recruiter call me and wanted to engage. The companys name is: I will not tell They suffered several Major Observation
- 5. 1. DESIGN VERIFICATION AND VALIDATION Failure to establish and maintain adequate procedures for verifying the device design. Design verification shall confirm that the design output meets the design input requirements, as required by 21 CFR 820.30 2. DESIGN HISTORY FILE Failure to establish and maintain a design history file for each type of device, as required by 21 CFR 820.30 3. PROCESS VERIFICATION AND VALIDATION : Failure to ensure, when the results of a process cannot be fully verified by subsequent inspection and test, that the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75 (a) Failure to establish procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met, as required by 21 CFR 820.75(b).
- 6. A follow up inspection will be required to assure that correction and/or corrective actions are adequate. Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the awarding of contracts. Additionally, premarket approval applications for the Class of devices to which the Quality System regulation violations are reasonably related to will not be approved until the violations have been corrected.
- 7. An Accident? Paper Trail Not properly documented Missing documents No SOP Assessment Weak internal auditing practices Documents not defendable
- 8. Identification of Gaps Standardization Practice Relearn Design Control The Risks What is CTQ and CQA Statistical Techniques Proper use of Lexicons Definitions V&V What is in V&V Understanding when to verify and when to validated SOP Test Method Validation & MSA Documentations Stages DHF The Regulatory Body
- 10. User Needs Concept Phase - VOC information - IDE - Concept Study - Clinical/Animal Studies - VOC Design Review - Intended Use Design Input DDP & Product Requirements Feasibility Definition Phase - Design Development Plan - Design Input Requirements - Risk Management - Design Reviews Design Development Process Design Review Design Output Medical Device Development Phase - Design outputs created (Specifications / Drawings / MSA / Test Methods Validation / DVT (Design Verification Test), Supplier Verification / Validation & Approval / etc.) - Design Reviews Device Qualification Phase - Packaging / Sterility Ver. & Val. - Device / Design Validation - Process Validation - DMR/DHR - Design Transfer / Review - Review and update Risks - Shelf Life Verification/Study - Design Freeze - R/A Submissions / Approval Product Closure Product Launch Product Launch - Post-Market Surveillance - Production Review - Return Analysis, RMR/RCA as Needed - Review and update RMF - Release product for sale ECO - Equipment / System Validation END of Life - Decommissioning Device Validation D.V.T.
- 11. Why are we talking about Risk. It is part of the QMS ISO14971 Is the How to identify the hazard associated with the device Estimate the risk associated with the hazard Risk Management Processes Elements Risk Identification / Analysis Risk Evaluation Risk Control Risk Assessment
- 12. CTQ - are key measurable characteristics of a component or process whose performance standards or specification limits that must be met in order to satisfy the customer requirement CQA - a physical, chemical, biological or microbiological property or characteristic that shall be within an appropriate limit, range, or distribution in order to ensure the desired product quality. Therefore: The purpose of CTQ is to convert user needs to a measurable requirement (Specification) While the purpose of CQA is to convert the CTQ further for business to implement in manufacturing. SO: CTQ is in the Design Control stage and the CQA is in the Manufacturing stage. Ref: Early,J.F. and O.Coletti. Section 3: The Quality Planning Process. Jurans Quality Handbook. 5thEd. 1999
- 13. When do we use the following words: Shall Should May Quiz Which of the statements is correct: 1. We may follow all the regulation in 21CFR 820 when we produce or manufacture medical device. 2. We shall follow our companys Quality System Regulation. 3. We should invest in our companys 401K
- 14. Verification is looking for an objective evidence that the product (which is a widget) is being produced correctly. Validation is looking for objective evidence that the widget is the correct product
- 15. Activities in: Verification Worst Case Analysis Thermal Analysis Fault Tree Analysis Package Integrity Analysis Biocompatibility Analysis Bioburden Analysis Leveraging Validation Types Validation of Process Validation of Test Methods Validation of Equipment Documents Validation Planning VMP Validation Protocol Validation Report Documentation Repository
- 16. An Example: Adhesive Material When is verification applicable and when is validation applicable
- 17. Subpart O or 820.250 Requires manufacturers to establish and maintain procedures for identifying valid statistical techniques Sampling Plans Attribute: N=ln(1-CL)/lnR Variable: n=3/P Capability Analysis Statistical Analysis others
- 18. Failure to document how to review sampling methods for adequacy for their intended use, as required by 21 CFR 820.250(b). Do what you say, Say what you do: One thing leads to another. Why do we need an SOP? The Purpose The Command How do we make it Compliant? Compliance/Training Team The Task Review Distribution Training Metrics
- 19. Definitions Difference between TVM and MSA Not much Deliverables Accuracy Precision Repeatability Reproducibility Specificity Sensitivity Linearity But why do we do it?
- 20. Contents of Design History File The contents will probably vary from class to class, company to company and from industry to industry In general, the contents should be: Design Development Plans Design Input Documentations Design Risk Documentation and Pointers (RMF) Design Output Documentations Design Reviews Documentations Design Verification Documentations Design Validation Documentations (including Shelf Life) Design Trace Matrices Documentations Design Transfer Documentation Change Control Documentations
- 21. An FDA Audit probability What will they look for.. Design Control SOP Did you properly audit your documents against the QSR Did I we do a good sample Change Controls Do we have any changes What is common sense in changes What is LESLI (LESsons Learned Index) Why Sampling Metrics
- 22. What do they normally do? Sequence Why Quality System MDR / Complaints / Adverse Events CAPA Trending QSIT Probability High DHF Documents Trace Matrices? Questions and documentations Are you ready? These are all valid concerns and expectation from FDA
- 23. When put all of the items together: Test Methodologies how do we standardized the configuration of documenting them We have discussed the Test Method Validation and MSA What are the critical requirements that should be met We have also discussed the background statistics What does the regulatory body expects from Verification and Validation records We have discussed an experience that I had when one of the company that got a warning letter and the activities that we did to remediate. In the last slide, I have given you example of what FDA will possibly ask so take note Validation lifecycle documentation multiphasic process We have discussed the different elements of validation with respect to Design Control and the phases involved.
- 24. PLEASE BE KIND TO ANIMALS LIKE ME For more questions please send me email me: melmaan2010@gmail.com