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  1. Abdullah
    Post

    Documentation of validation and qualification protocols

    Exactly thats it :p
    Post by: Abdullah, Jan 19, 2016 in forum: Qualification & Validation (Also 21 CFR Part 11)
  2. Abdullah
    Post

    Validation master plan

    Thanks a million Jennifer
    Post by: Abdullah, Jan 19, 2016 in forum: Qualification & Validation (Also 21 CFR Part 11)
  3. Abdullah
    Thread

    Validation training

    HI every Body Do there any body know an online training entity that offers training on validation ?? thanks for your help
    Thread by: Abdullah, Jan 17, 2016, 1 replies, in forum: Training - Internal, External and Web-Based
  4. Abdullah
    Thread

    Validation master plan

    Dear All, I hope you have a nice time regarding the Validation Master Plan (VMP); what could a typical VMP includes and how to prepare such a...
    Thread by: Abdullah, Jan 17, 2016, 3 replies, in forum: Qualification & Validation (Also 21 CFR Part 11)
  5. Abdullah
    Post

    Documentation of validation and qualification protocols

    ok thats great, but there is one more thing; according to ISO 13485, it is required to control each document according to a documentation system....
    Post by: Abdullah, Jan 12, 2016 in forum: Qualification & Validation (Also 21 CFR Part 11)
  6. Abdullah
    Post

    Documentation of validation and qualification protocols

    so i need to prepare the protocol with empty tables and forms, then make a report including the same tables and forms to fill the actual results...
    Post by: Abdullah, Jan 11, 2016 in forum: Qualification & Validation (Also 21 CFR Part 11)
  7. Abdullah
    Thread

    Documentation of validation and qualification protocols

    Dear all, I hope you are having a great time where ever you are ^_^ i have a question which is: when a qualification or a validation protocol...
    Thread by: Abdullah, Jan 11, 2016, 9 replies, in forum: Qualification & Validation (Also 21 CFR Part 11)
  8. Abdullah
    Post

    AQL

    actually, i don't know, but i feel it is not clear or easy to understand when to use the Special Inspection levels and the general inspection...
    Post by: Abdullah, Dec 28, 2015 in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  9. Abdullah
    Post

    Qualification of HVAC system

    Candi, what should we call an environmentally controlled room (Temperature, Humidity and airborne particles) on the the other hand; what could...
    Post by: Abdullah, Dec 28, 2015 in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  10. Abdullah
    Post

    Qualification of HVAC system

    thank you very much Jennifer, and i Hope you the best ^_^
    Post by: Abdullah, Dec 28, 2015 in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  11. Abdullah
    Post

    AQL

    Do you have a link for the latest issue of AQL standard ?
    Post by: Abdullah, Dec 28, 2015 in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  12. Abdullah
    Post

    AQL

    Thanks David
    Post by: Abdullah, Dec 28, 2015 in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  13. Abdullah
    Thread

    AQL

    HI Every Body, sorry because i have lot of questions :p what is the reference for the AQL tables we see on the web, and how to use them ?...
    Thread by: Abdullah, Dec 28, 2015, 9 replies, in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  14. Abdullah
    Post

    Qualification of HVAC system

    thanks a lot Jennifer :)
    Post by: Abdullah, Dec 28, 2015 in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  15. Abdullah
    Post

    Qualification of HVAC system

    Yes jennifer, the qualification will be for a cleanliness production area that is separated from packaging area (for strips cutting and primary...
    Post by: Abdullah, Dec 27, 2015 in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  16. Abdullah
    Thread

    Qualification of HVAC system

    Dear All, Regarding the Qualification of HVAC system; any one has a template for a qualification protocol of HVAC system ?!!
    Thread by: Abdullah, Dec 27, 2015, 9 replies, in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  17. Abdullah
    Post

    Assembly and Packaging areas separation ??!!!

    Thanks for all, The point is we have a manufacturing line for the medical devices (i mean pressure meters , thermoneters. And so on) but we do not...
    Post by: Abdullah, Dec 23, 2015 in forum: Medical Devices (21 CFR Part 820)
  18. Abdullah
    Thread

    Assembly and Packaging areas separation ??!!!

    Dear All,,, Regarding to the manufacturing of Medical Devices; is it a must (by any of the well known authorities such as FDA or WHO,...) to have...
    Thread by: Abdullah, Dec 22, 2015, 9 replies, in forum: Medical Devices (21 CFR Part 820)
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