Principal, Quality & Compliance
Eliquent Life Sciences, District of Columbia, United States
David Elder brings more than 36 years of extensive regulatory experience to his role at ELIQUENT Life Sciences.
David began his 23-year FDA career as an Investigator in the Boston District Office where he conducted domestic and foreign inspections and investigations in pharmaceutical, medical device, and biologics program areas. He was selected as a Compliance Officer and later as the Director of the Compliance Branch with responsibility for assessment of inspection reports and evidence, initiation of compliance actions, and evaluation of compliance action effectiveness.
David transferred to FDA headquarters when he was selected as the Director of the FDA Office of Enforcement in 2003, a position he held for the next six years. In this Senior Executive Service (SES) position, David led the Office with responsibility for agency compliance and enforcement policy, health fraud investigations, guidance and regulation review, agency recall policy and operations, and enforcement strategy and case review. In 2009, David transferred from the Office of Enforcement to the Office of Regional Operations where he led the Office with responsibility for policy and operations related to foreign inspections, domestic inspections, emergency response investigations, import operations, and field regulatory science operations.
At ELIQUENT, with 23 years of FDA experience and 13 years of worldwide consulting experience, David provides strategic guidance and support to pharmaceutical and medical technology companies in areas including: strengthening corporate quality systems; developing compliance strategies; supporting inspections and ensuring inspection readiness; assisting industry clients and legal counsel in developing and communicating corrective action plans in response to compliance issues; verifying completed corrective actions; executive training and coaching; and performing due diligence.
The Device Design Change Life Cycle Experience
Tuesday, April 22, 2025
8:30 AM – 4:30 PM East Coast USA Time