Retired, FDA
Phillip Pontikos was a Medical Device National Expert working for the Office of Inspections and Investigations (OII) of the Food and Drug Administration and retired in April 2025. He joined FDA in 1994 as an Investigator in the Brunswick, Ohio, Resident Post of Cincinnati District. In 2000, Pontikos moved to Columbus, Ohio, where he currently resides. Pontikos is responsible for conducting medical device inspections domestically and abroad; he is a Level II Certified Medical Device Investigator and Medical Device Performance Auditor. Pontikos has assisted in the development of and actively participates as a trainer for numerous FDA courses including Computer Aided Inspections, Basic Medical Device, Industrial Sterilization for Drugs/Devices, and Process Validation. He has also served as a mentor and acting Supervisor.
The Device Design Change Life Cycle Experience
Tuesday, April 22, 2025
8:30 AM – 4:30 PM East Coast USA Time
FDA Medical Device Inspections
Wednesday, April 23, 2025
10:05 AM – 10:50 AM East Coast USA Time
FDA’s QMSR Implementation Status
Wednesday, April 23, 2025
3:30 PM – 4:15 PM East Coast USA Time
Breakout #2: Are You Processing and Investigating Complaints to the Right Level?
Thursday, April 24, 2025
12:30 PM – 2:00 PM East Coast USA Time