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  • 1.  PRRC

    Posted 19-Jul-2022 18:50
    Hello,
    How do you show evidence of appointed PRRC? Do you guys write a memo or do you mention the appointment in your quality manual ect...

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    Bedwuine Senatus
    QA/RA Director
    Springfield NJ
    United States
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  • 2.  RE: PRRC

    Posted 20-Jul-2022 03:04
    Hi Bedwuine, 

    First you need to write an Appointment Letter, which will be attached to the Qualilty Manual. Then you need to mention this appointment in the QM (ch. 5) and also in the organization chart, as well as add PRRC's minimum requirements in the form regarding personnel and in the job description. 
    Following you will have to implement PRRC requirements deriving from article 15 MDR in the relevant QMS's procedures and related forms.

    Let me suggest you to follow this webinar provided by my company regarding PRRC's requirements; it lasts about 2 hours and it gives you all need in order to have a clearer vision about this.

    https://skillhub.md-24.net/videocorsi/persona-responsabile-rispetto-normativa-prrc-come-tutelarsi/

    That's a platform called SkillHub and you only need to create your own profile and register with no charge in a few clicks.

    Hope it was helpful
    Regards,



    ------------------------------
    Valentina Faziani
    Regulatory Affairs Specialist
    Thema s.r.l.
    Italy
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    Original Message


  • 3.  RE: PRRC

    Posted 20-Jul-2022 07:38
    Good day Bedwuine,

    We placed a letter appointing the person in their personnel file along with their qualifications and indicated it in their training record.  This was acceptable during our past 2 audits for MDR compliance.

    Best regards,

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    D Michelle Williams
    VP - Operations
    United States
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    Original Message


  • 4.  RE: PRRC

    Posted 20-Jul-2022 09:56
    Dear all,

    we were fine as well with filing a memo summing up the needed qualifications per article 15 MDR and adding the evidence (resume, certifiacte of university).
    How ever, we had an auditor, that requested specifically a training record, that the PRRC is trained on his responsibilites. Fortunately, we had this.

    Best
    Lutz

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    Lutz Babilon
    Director QM/RA
    Freiburg im Breisgau
    Germany
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    Original Message


  • 5.  RE: PRRC

    Posted 20-Jul-2022 10:10

    Dear all,

     

    We had to have the same proof as Lutz stated.  The training record of the PRRC has to show they are qualified.

     

    Best regards,

     

     

    D. Michelle Williams, CESCO

    VP – Operations

     

    Action Products, Inc.

    www.actionproducts.com

    301.797.1414 X1022

     

    https://www.linkedin.com/in/dmwilliamsvpopapiwvu88

     

     

    Action-MMD-Ribbon_Logo_5in_cmyk

     




    Original Message


  • 6.  RE: PRRC

    Posted 21-Jul-2022 21:44
    Thanks Michelle..,
    Yes i think i will do the letter of appointment..because this is what we did in the past for Quality management Rep

    ------------------------------
    Bedwuine Senatus
    QA/RA Director
    Springfield NJ
    United States
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    Original Message


  • 7.  RE: PRRC

    Posted 21-Jul-2022 07:07
    Hi Bedwuine
    In addition to appointment and training record, some NB´s auditors also want to see how the manufacturer within QMS shows the ability of PRRC to do practicing (in practice) all the required activity, for example, by a record of the internal audit focused on practical PRRC´s abilities.


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    Evangelos Tavandzis
    Lead Auditor, Consultant
    Praha
    Czech Republic
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    Original Message


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