process validation & verification (v&v) for medical devices

This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. [email protected] Process Validation and Verification Rina Nir [email protected] www.RadbeeQMS.com 105/2014

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This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. [email protected] Process Validation and Verification From Prototype To Product Six Focus Areas 305/2014

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This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. [email protected] 05/2014 Erez Adiv, MedicSense Neomi Katz, Pharma Quality Europe Chris Monchinski, Automated Control Sun Kim, QbD Works Markus Roemer, Comes Compliance Services Kirsi Rosenqvist, Medtentia Line Szlamka, 4Echo, member of MEPY BENELUX One anonymous (off-record) Interviewees: (In alphabetic order)

This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. [email protected] GET YOUR CEO COMMITTED #1

This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. [email protected] Management Commitment? Quality We stand for quality. We live our quality system according to ISO 9001:2008 and ISO 13485:2012. www..com/quality 805/2014

This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. [email protected] Management Commitment! Using photo: http://upload.wikimedia.org/wikipedia/commons/1/1d/ Auguste_Rodin-The_Thinker-Legion_of_Honor-Lincoln_Park-San_Francisco.jpg by Yair Haklai . Using: Entypo Font 905/2014

This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. [email protected] http://www.imdrf.org/documents/doc-ghtf-sg3.asp 1005/2014

This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. [email protected] http://www.imdrf.org/documents/doc-ghtf-sg3.asp 1. Body - 11 pages 2. Intro to statistics 10 pages 3. Example 12 pages 1105/2014

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This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. [email protected] Culture Change 1305/2014

This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. [email protected] What Could Go Wrong? 1405/2014

This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. [email protected] Affected pumps were manufactured in 1998. Recall issued in 2014! 1605/2014

This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. [email protected] ESTABLISH AN INTERDISCIPLINARY TEAM # 2

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This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. [email protected] What variability do we allow? 1905/2014

This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. [email protected] What Risk Exists If Parameters Are Out Of Range? Diameter Composition Curvature Soaking liquid Etc. 2005/2014 Are They All Equally Important?

This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. [email protected] Consistently Producing A Stunning Product 2105/2014 The Free4 Concept Wheelchair. Designer: Mr. Markus Ofner, FH JOANNEUM GesmbH

This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. [email protected] Requires Multidisciplinary Expertise 2205/2014 The Free4 Concept Wheelchair. Designer: Mr. Markus Ofner, FH JOANNEUM GesmbH

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This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. [email protected] Contractor Selection According to level of risk (criticality). Expertise. ISO-13485 for this particular type of process. Certification by a reputed body. Serves big companies. Pre-contract audit. Quality agreement. 3105/2014

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This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. [email protected] Quality Agreement Quality decision details. Certification Of Compliance and other forms. Quality process commitments (V&V). Forbid non-authorized modifications. Record retention (with Escrow agreement). Audit right. 3405/2014

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This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. [email protected] Know Your Process If you ask people to describe their process, very often different people will describe it differently. There is no consensus about how the process is. They have many work instructions but not a single schema which describes the process. Markus Roemer 3705/2014

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This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. [email protected] Obtaining a process that consistently conforms to requirements requires a balanced approach using both mistake proofing and variation reduction tools GHTF Guideline 3905/2014

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This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. [email protected] MANAGE THE MANUFACTURING RECORDS #6

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This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. [email protected] One FDA Investigation Report http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/UCM382514.pdf 4305/2014

This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. [email protected] A Thorough Investigation http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/UCM382514.pdf 4405/2014

This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. [email protected] Controlling Computerized Systems http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/UCM382514.pdf 4505/2014

This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. [email protected] Paper-Forms and Back-Dating http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/UCM382514.pdf 4605/2014

This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. [email protected] Do Not Use Sticky Notes! http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/UCM382514.pdf 4705/2014

This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. [email protected] Using Excel In Manufacturing 4805/2014

This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. [email protected] When Subcontracting Include records related commitments in the Quality Agreement: Access Retention Escrow Include records investigation in your audits. 4905/2014

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This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. [email protected] 1. Gain CEO commitment. 2. Establish a multidisciplinary team. 3. Start Early. 4. Know your suppliers and sub-contractors. 5. Map your process. 6. Manage the manufacturing records. 5105/2014

This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. [email protected] 05/2014 Erez Adiv, MedicSense Neomi Katz, Pharma Quality Europe Chris Monchinski, Automated Control Sun Kim, QbD Works Markus Roemer, Comes Compliance Services Kirsi Rosenqvist, Medtentia Line Szlamka, 4Echo, member of MEPY BENELUX One anonymous (off record) Interviewees: (In alphabetic order) [email protected] www.RadbeeQMS.com