Dimitris Papamatthaiakis

usp data integrity analytical development aqbd doe quality control european pharmacopoeia ep regulatory design of experiment analytical target profile analytical control strategy analytical quality by design rca root cause analysis cause and effect diagram fishbone ishikawa risk assessment method development humidity stress heat stress uv stress oxidative stress base stress acid stress degradation pharmaceuticals stress testing stability validation performance parameters quality assurance continuous improvement data quality measurement uncertainty measurement analytical method iso/iec98 eurachem research and development r&d analytical method development analytical method validation method qualification method validation control strategy modr method operable design region design space atp six sigma lean tqm total quality management human error data approval data review electronic records violations root causes of data integrity violations dynamic electronic record staticelectronic record data lifecycle recording data meta data raw data factorial design analytical quality bydesign qbd anova quality by design design of experiments heat maps fmea ich method design space risk management for analytical methods risk management ep chapter 2.6.13 ep chapter 2.6.12 total yeast and mould count total aerobic microbial count qc cfu sop united states pharmaceopoeia product control negative control recovery tymc tamc suitability protocol method suitability microbial limit test international conference on harmonization united sstates pharmacopoeia ich regulatory update global regulatory update target measurement uncertainty process risk management problem solving process problem solving tools 5 why's approach deviation investigation oos investigations oos process oos method validation. method operable design region (modr) failure mode and effects analysis (fmea) risk prioritization number (rpn) design of experiment (doe) wet and dry analysis laser diffraction particle size distribution