Dr. Loren Gelber has more than 40 years of experience in pharmaceutical industry regulatory compliance. She worked for about 10 years at the FDA, including as a reviewer in the Division of Generic Drugs. As an early user of HPLC, she was involved in establishing the FDA requirements for the validation of HPLC methods, and she published the results of her validations both within FDA and externally. She then transitioned to industry, working for four different pharmaceutical companies. She has participated in many FDA inspections, often as the lead person from the pharmaceutical firm. For the last 13 years, she has been a regulatory compliance consultant, both for consulting companies and independently.