Drug Makers Focus on Involving Top Management to Prevent Quality Failure

A Play Book for getting C-level attention to quality could be to wait for the fiasco. But speakers at the recent ISPE Washington conference had some better ideas. They talked about creating an ICH Q10 quality system that brings senior managers into the loop. They explored the importance of establishing a 'quality culture,' which starts with senior management. Don't delegate the quality system design to Quality, they said. And make sure there is a strong and responsive management review system in place. They also went over some of the common objections to investing in quality - and their favorite rebuttals. They explored the use of 'product quality stewards' and described a difficult investigation into mysterious glass breakages.