Paul Daniel, a senior regulatory compliance expert at Vaisala, has 15 years of validation experience in the pharmaceutical and medical device industries, and has worked on a wide range of qualification projects, including process, cleaning, shipping, laboratory equipment, packaging, software, network, and computer validation, and extensive practical grounding in applying the good manufacturing practices principles of the FDA 21 CFR Parts 11, 210, 211, and 820, and authoring and executing validation protocols for pharmaceutical manufacturing and software validation with a risk-based approach drawn from GAMP guidelines. Daniel has a bachelor’s degree in biology (with honors) from the University of California, Berkeley.