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Home › Business Help › Food Safety
Status: Completed
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Food Safety
Date Posted: 10/04/2021
Category: Business
Due Date: 16/04/2021
Instruction
A cGMP report needs to be written. Further instructions will be given once assigned
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Rated 9.65 earned 38907.21 around 1242 assignments.
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  • Many thanks indeed, I'll take my time and go through every file
    eveey | Apr 10, 2021, 03:37 AM
  • I'll explain each one of them there's 1- Assignment: this is simply what we were assigned by the professor. 2-Resources: use this resources only or find new ones solely at https://www.ecfr.gov/cgi-bin/ECFR?page=browse. the "Written inspection report example" is what I based off the Draft document and "Audit inspections requirements and standards" is what is required from these audits, you will mostly be referencing the "111 Code of Federal Regulations 21" links are in the file as well
    User_2879 | Apr 10, 2021, 03:46 AM
  • Thank you so much, that's clearer now
    eveey | Apr 10, 2021, 03:49 AM
  • 3- Draft: is what I have written so far, and is mostly completed, please add any sections that might be relevant and I might have missed. In the "MANUFACTURING /DESIGN OPERATIONS" section "Observation X, X & X under the caption “OBJECTIONABLE CONDITIONS AND SUGGESTED CORRECTIVE ACTIONS”, address the failure to…" needs to be linked to the observations found in "OBJECTIONABLE CONDITIONS AND SUGGESTED CORRECTIVE ACTIONS" section, in which you describe the observation found in the assignment document and reference the appropriate part of the code of federal regulations. I have only placed 10 observations but there could be more, the"Reference: 21 CFR 111.XX" is just a place holder, and a suggested corrective action and procedure needs to be written for the company to solve the observation.
    User_2879 | Apr 10, 2021, 03:49 AM
  • I will offer continuation and do a great job on this
    eveey | Apr 10, 2021, 03:50 AM
  • Once you read all documents and the instructions written on these messages, let me know if you have any questions
    User_2879 | Apr 10, 2021, 03:50 AM
  • Yes, I will add that, and anything you might have missed. I will highlight with different color so that you see what's been added
    eveey | Apr 10, 2021, 03:51 AM
  • Sure, I'll let you know, but I believe so far so good
    eveey | Apr 10, 2021, 03:52 AM
  • By the way, in the "Written inspection report example" document, you should see how observations are written and what is expected of them
    User_2879 | Apr 10, 2021, 03:55 AM
  • Sure, alright
    eveey | Apr 10, 2021, 04:00 AM
  • Hello, would it be okay to give me an extension till tomorrow, I promise good work on this
    eveey | Apr 16, 2021, 11:05 AM
  • It is progressing well, if its okay with you, allow me to upload the final draft by 17th, early morning
    eveey | Apr 16, 2021, 14:54 PM
  • Sure thing, thank you for letting me know
    User_2879 | Apr 16, 2021, 18:24 PM
  • H, uploaded, take a look and let me know your thoughts about it. Thank you so much for your patience
    eveey | Apr 17, 2021, 10:24 AM
  • Hello, a few things I noticed: - We should be able to use more than one reference from the code, I believe the observations are so severe that we should be able to link them to several references of the 21 CFR, would you agree? - On observation 10 it references "21 CFR 111.16 – Requirements for sanitation Supervisors" however, none of the personnel involved are sanitation staff, is there something I am missing?
    User_2879 | Apr 17, 2021, 17:10 PM
  • Hi, I have gone over one more time. 1) For observation 10, I have revised to reflect the supervisory role as it relates to keeping necessary records
    eveey | Apr 18, 2021, 08:35 AM
  • 2) About linking to several codes, it could be possible, but it may also bring confusion as opposed to picking on specific code and explaining in full. We may risking attaching to codes that may remotely but not directly relate to a specific observation. What's your view about that?
    eveey | Apr 18, 2021, 08:38 AM
  • *risk
    eveey | Apr 18, 2021, 08:38 AM
  • That's fine, let's try it and i'll go over them. I work closely with the USDA and is not rare for them to reference more than one code in their observations. It looks pretty good so after that we should be fine
    User_2879 | Apr 18, 2021, 16:45 PM
  • Also no rush the paper is due wednesday if I can get it by then I can check it and submit it.
    User_2879 | Apr 18, 2021, 16:45 PM
  • Alright, thanks for clarifying, I will revise it more
    eveey | Apr 18, 2021, 17:10 PM
  • Hello, has this been completed yet?
    User_2879 | Apr 21, 2021, 16:04 PM
  • Hi, I have not been able to complete it. Can I upload 10hrsor so, please I request
    eveey | Apr 21, 2021, 16:15 PM
  • Yeah that’s fine
    User_2879 | Apr 21, 2021, 18:57 PM
  • Hi, added a handful of reference codes- you were right. Uploaded the new doc
    eveey | Apr 22, 2021, 07:51 AM
  • Thank you very much!
    User_2879 | Apr 22, 2021, 16:28 PM
  • All the best on this, friend. Get a top grade!
    eveey | Apr 23, 2021, 04:03 AM
  • hey friend are you available? I will be posting work soon
    User_2879 | Jun 02, 2021, 03:18 AM
  • Hello, yes I am available :)
    eveey | Jun 02, 2021, 03:29 AM
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