7 Process Validation Report Tips
These are the first 7 I would give someone drafting a process validation report (+PDF available with more tips!)
- Sep 2, 2021
Root Cause Analysis: 3 Methods
An introduction to RCA, problem definition, and 3 common methods (+download PDF)
67 views
- Aug 23, 2021
Medical Device Process Validation - Overview: Part 2
Continuation of Process Validation essentials discussion (+download PDF)
49 views
- Aug 18, 2021
Medical Device Process Validation - Overview: Part 1
We begin our discussion of Process Validation essentials in Part 1 (+download PDF).
140 views
- Aug 7, 2021
Medical Device Design Verification and Validation: An Overview
Overview of DV&V using 3 methods with introductory concepts (+download PDF).
129 views
- Jul 15, 2021
Process Validation vs QC Inspection: 5 Differences to Know
These 5 differences result from their radically different aims and assumptions.
61 views
- Jun 21, 2021
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.
116 views
- Jun 8, 2021
What’s the difference between Cpk and Ppk?
How they are calculated can have a profound difference in their values for the process.
98 views
- May 31, 2021
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.
37 views
- May 26, 2021
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...
30 views
- May 19, 2021
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...
39 views