How often have you seen ’employee to be retrained’ as a response in a CAPA? What about ’employee to be requalified?’ I will take odds that you have seen those sentences more than ‘training system to be redesigned’ or even ’employees to be allowed time to practice.’  Malcolm Gladwell’s ‘10,000 hour’ rule posits that one needs to put in 10,000 hours of practice to achieve world class. It took Bill Gates seven years to assemble his 10,000 hours; in between 1968 (age 13) when he wrote his first program and 1975 when he launched Microsoft. He spent 1973 working almost full time (plus weekends) as a programmer under the guise of independent study.  Our patients deserve the best therapies and medicines the world can provide them, the regulators demand it. Yet, at what stage of our employees career’s do we expect them to produce ‘world class’ products?