Top DOE MistakesBecause Design of experiments (DOEs) are so powerful, yet often costly in terms of time and resources, the experimenter should be extra...
Top PFMEA MistakesIn manufacturing, a process Failure Mode and Effects Analysis (pFMEA), is an indispensable tool for identifying potential production...
These are the Top 8 requirements for a Medical Device Manufacturing Engineer according to ChatGPTIt's essential to have a strong blend of education, experience, and skills to be successful in this highly regulated and technically...
Medical Device Process Validation: What are the REAL Odds of Passing?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 TipsThese are the first 7 I would give someone drafting a process validation report (+PDF available with more tips!)
Root Cause Analysis: 3 MethodsAn introduction to RCA, problem definition, and 3 common methods (+download PDF)