Five Key Processes for GMP Deviation Investigation
When things go wrong, there are five non-negotiable processes that should be defined on your deviation investigation standards of practice (SOP): immediate engagement, gemba, triaging using a documented risk assessment, using the Klein process to det...
New EU Medical Device Regulation Adopted
This year has brought significant changes to the regulatory landscape across Europe, following the publication of the new European medical device regulation (MDR) and in-vitro diagnostics regulation (IVDR).
COPQ in the Pharmaceutical Industry
COPQ is increasingly valuable for the pharmaceutical and medical device industries, where maximising product quality is paramount and defect reduction has an additional knock-on effect.