Medical Device Process Validation: What are the REAL Odds of Passing?
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Statistics tell us: (1) Passing a typical 3-lot PQ is not easy; (2) What to do about it. In medical device process validation (IQ OQ PQ)...
7 Process Validation Report Tips
These are the first 7 I would give someone drafting a process validation report (+PDF available with more tips!)
Root Cause Analysis: 3 Methods
An introduction to RCA, problem definition, and 3 common methods (+download PDF)
Medical Device Process Validation - Overview: Part 2
Continuation of Process Validation essentials discussion (+download PDF)
Medical Device Process Validation - Overview: Part 1
We begin our discussion of Process Validation essentials in Part 1 (+download PDF).
Medical Device Design Verification and Validation: An Overview
Overview of DV&V using 3 methods with introductory concepts (+download PDF).
Process Validation vs QC Inspection: 5 Differences to Know
These 5 differences result from their radically different aims and assumptions.
The REAL odds of passing a Process Validation - Part 4
In Part 4 we look at why it is highly advantageous to use Double-Sampling plans whenever possible for attribute analysis studies.
What is the difference between Cpk and Ppk?
How they are calculated can have a profound difference in their values for the process.
The REAL odds of passing a Process Validation - Part 3
In Part 3, we compare real sampling plans vs. the ideal sampling plan as sample size increases.
The REAL odds of passing a Process Validation - Part 2
In Part 1 we concluded that to have a reasonable chance at passing 3 consecutive lots, the process % defective must be much lower than...
The REAL odds of passing a Process Validation
Statistics tell us passing a PQ is not easy! In validation we’re providing objective evidence the process is capable of successfully...
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