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Quality Experts
@quality-experts
Trusted Member
Joined: Apr 15, 2025
Last seen: Jul 14, 2026
Topics: 0 / Replies: 92
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RE: Risk assessment of Critical Method Parameters (CMPs)

"The statistical approach underlying an assay failure risk assessment can take many forms. Populating the various fields of an FMEA can be supported b...

1 year ago
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RE: Control Strategy

"In my opinion, using trending data to complement—or even shorten—validation studies should not be an issue, provided it's done appropriately. The pri...

1 year ago
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