Sep 9, 20217 Process Validation Report TipsThese are the first 7 I would give someone drafting a process validation report (+PDF available with more tips!)
Sep 2, 2021Root Cause Analysis: 3 MethodsAn introduction to RCA, problem definition, and 3 common methods (+download PDF)
Aug 23, 2021Medical Device Process Validation - Overview: Part 2Continuation of Process Validation essentials discussion (+download PDF)
Aug 18, 2021Medical Device Process Validation - Overview: Part 1We begin our discussion of Process Validation essentials in Part 1 (+download PDF).
Aug 7, 2021Medical Device Design Verification and Validation: An Overview Overview of DV&V using 3 methods with introductory concepts (+download PDF).
Jul 15, 2021Process Validation vs QC Inspection: 5 Differences to KnowThese 5 differences result from their radically different aims and assumptions.
Jun 21, 2021The REAL odds of passing a Process Validation - Part 4In Part 4 we look at why it is highly advantageous to use Double-Sampling plans whenever possible for attribute analysis studies.
Jun 8, 2021What’s the difference between Cpk and Ppk?How they are calculated can have a profound difference in their values for the process.
May 31, 2021The REAL odds of passing a Process Validation - Part 3In Part 3, we compare real sampling plans vs. the ideal sampling plan as sample size increases.
May 26, 2021The REAL odds of passing a Process Validation - Part 2In Part 1 we concluded that to have a reasonable chance at passing 3 consecutive lots, the process % defective must be much lower than...
May 19, 2021The 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...