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

Download Process Validation & Verification (V&V) for Medical Devices

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Six focus areas to drive a succesful process V&V. Presentation from the MedTeck UK 2014 Conference.

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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. Rina.Nir@RadBee.com Process Validation and Verification Rina Nir Rina.Nir@RadBee.com www.RadbeeQMS.com 105/2014
  • This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. Rina.Nir@RadBee.com 205/2014
  • This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. Rina.Nir@RadBee.com Process Validation and Verification From Prototype To Product Six Focus Areas 305/2014
  • This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. Rina.Nir@RadBee.com Consistent Output 405/2014
  • This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. Rina.Nir@RadBee.com Controlled Process 505/2014
  • This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. Rina.Nir@RadBee.com 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. Rina.Nir@RadBee.com 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. Rina.Nir@RadBee.com 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. Rina.Nir@RadBee.com 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. Rina.Nir@RadBee.com 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. Rina.Nir@RadBee.com 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
  • This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. Rina.Nir@RadBee.com Culture Change 1205/2014
  • This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. Rina.Nir@RadBee.com 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. Rina.Nir@RadBee.com 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. Rina.Nir@RadBee.com 1505/2014
  • This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. Rina.Nir@RadBee.com 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. Rina.Nir@RadBee.com ESTABLISH AN INTERDISCIPLINARY TEAM # 2
  • This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. Rina.Nir@RadBee.com Where Magic Happens 1805/2014
  • This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. Rina.Nir@RadBee.com 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. Rina.Nir@RadBee.com 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. Rina.Nir@RadBee.com 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. Rina.Nir@RadBee.com Requires Multidisciplinary Expertise 2205/2014 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. Rina.Nir@RadBee.com START EARLY # 3
  • This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. Rina.Nir@RadBee.com 2405/2014
  • This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. Rina.Nir@RadBee.com 2505/2014
  • This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. Rina.Nir@RadBee.com Wishful Thinking 2605/2014
  • This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. Rina.Nir@RadBee.com A More Practical Approach 2705/2014
  • This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. Rina.Nir@RadBee.com V Model Planning 05/2014
  • This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. Rina.Nir@RadBee.com KNOW YOUR SUPPLIERS AND SUBCONTRACTORS #4
  • This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. Rina.Nir@RadBee.com Not Equal Partners 3005/2014
  • This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. Rina.Nir@RadBee.com 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
  • This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Photos are copyrighted as per their respective license. Rina.Nir@RadBee.com Quality Decision 3205/2014

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