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MR John Minier, RAC

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United States

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RE: When an FDA investigator asks for electronic records

Posted By John Minier 21-Mar-2024 16:56
Found In Egroup: Regulatory Open Forum \ view thread
For the sake of FDA document security the investigator could not download the documents, but he could read them while off-site. Any documents he wanted to keep, we gave him on his flash drive. Kind of odd since I was downloading them from the DropBox folder to the flash drive. Anyway, it worked for him. ...

RE: When an FDA investigator asks for electronic records

Posted By John Minier 21-Mar-2024 09:53
Found In Egroup: Regulatory Open Forum \ view thread
We set up a folder in DropBox and invite the investigator to share that folder (only). That way we can review the documents before uploading to make sure it is the current version and record what was shared. We have done this for several FDA inspections and also audits. We have never had a complaint. ...

RE: CER , CEP -MDR

Posted By John Minier 15-Aug-2023 09:03
Found In Egroup: Regulatory Open Forum \ view thread
Anon, Also, please consider the time that it takes to review a CER if the reviewer has to keep looking up information in the CEP. You are paying for this reviewer's time and the easier it is to find the CEP information by repeating it in the CER will save you unnecessary costs. Regards, ------ ...

RE: CAPA Reporting in PSURs

Posted By John Minier 20-Jul-2023 14:45
Found In Egroup: Regulatory Open Forum \ view thread
Thanks, all, for your excellent input. I am writing an SOP on PSUR content and wanted to clarify the regulation scope in my mind first. These comments helped me do just that. Best regards, ------------------------------ John Minier, RAC Consultant, Principal ------------------------------

CAPA Reporting in PSURs

Posted By John Minier 19-Jul-2023 18:03
Found In Egroup: Regulatory Open Forum \ view thread
I'm looking for a consensus on the reporting of CAPAs in PSURs. MDCG 2022-21 Guidance for PSURs references Articles 83.4 and 86 in regard to CAPA reporting. MDR Article 83.4 states: If, in the course of the post-market surveillance, a need for preventive or corrective action or both is identified, ...