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9
Dear Members, I really appreaciate your comments on the following question: are the requirements from the Pharma ...
Jose Dorbecker
Mar '23
David Manalan
Mar '23
There is no requirement for annual product review per se, and no retention sample requirement unless it's part of ...
1
13
Hello, We have recently started to take an in-depth look at our CAPA system. Our QMS currently states, “a CAPA may be ...
Monica Deo
Sep '22
George Marcel
Oct '22
@Monica Deo
Hello Monica, I would also include risk.
If things are one off or infrequent and easily corrected, with ...
4
32
Hi Everyone, What are the requirements for Medical Device Sampling Plan justification? I am looking for a ...
Alireza Khosh
Jun '22
Edwin Bills
Jun '22
Sampling plans must be statistically valid. The best way to do this is thru standards such as those available thru ...
David Manalan
Jun '22
Ajoy Basu
Jun '22
Hi Alireza,
While there is no definitive guidance on sampling plans from the FDA, have used the following for ...
Edwin Bills
Jun '22
For Medical Devices FMEA Risk is not the same as ISO 14971 Risk. You should use Risk Analysis Risk and not FMEA Risk. ...
7
What are the sample survey questions you'd ask if your supplier is a distributor as opposed to manufacturers? Any ...
Shamantha Gunawardena
Mar '22
14
Hello All, I am pursuing a Quality and Regulatory Specialist position in a medical device company and I need to ...
Timothy McShane
Nov '21
