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@Monica Deo
Hello Monica, I would also include risk.
If things are one off or infrequent and easily corrected, with ...

Sampling plans must be statistically valid. The best way to do this is thru standards such as those available thru ...


Hi Alireza,
While there is no definitive guidance on sampling plans from the FDA, have used the following for ...

Forum Topic List
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CAPA generation criteria for Medical Device
by Monica Deo - Sep 12, 2022 8:47 pm - 1
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Re: CAPA generation criteria for Medical Device
by George Marcel
Oct 10, 2022 9:49 pm
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CAPA generation criteria for Medical Device
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Medical Device Sampling Plan justification
by Alireza Khosh - Jun 24, 2022 1:57 pm - 4
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Re: Medical Device Sampling Plan justification
by Edwin Bills
Jun 27, 2022 7:28 am
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Medical Device Sampling Plan justification
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Vendor Qualification of Distributors
by Shamantha Gunawardena - Mar 24, 2022 10:31 pm - 0
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Vendor Qualification of Distributors
by Shamantha Gunawardena
Mar 24, 2022 10:31 pm
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Vendor Qualification of Distributors
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Looking for help on ISO standards
by Timothy McShane - Nov 24, 2021 10:56 pm - 0
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Looking for help on ISO standards
by Timothy McShane
Nov 24, 2021 10:56 pm
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Looking for help on ISO standards