Quality by Design:

a. was invented by the FDA

b. Emphasizes process control

c. focuses on the design of experiments and clinical trials

d. is a statistical design method

e. enables greater regulatory flexibility

Quality by Design is

Answer: b. Emphasizes process control

Explanation:

Quality by design Mainly emphasizes process control which helps to Recreate the new designs to come in to operations in the industry. So this option is selected. The last option is suitable with quality by design that Enables greater regulatory flexibility in future by the outcome of the improvement and advantages in the system. The quality by design was first outlined by Joseph M. Juran and then it was adopted by FDA so the option invented by the FDA is not selected. The remaining options is that focuses on the design of experiments and clinical trials is not selected because it is not a part of QbD and the statistical design method is used in the design of Six sigma so it is not mentioned in the QbD.