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FDA Medical Device Inspections

Susan Matthias – FDA (Virtual) ### 2544309###Moderator###Consumer Safety Officer, Special Assistant, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)###FDA (Virtual)###
Moderator: Susan Matthias – FDA (Virtual)
### @@@ Phil Pontikos – Retired, FDA ### 2544315###Moderator######Retired, FDA###
Moderator: Phil Pontikos – Retired, FDA
### @@@ Anne Reid – FDA (Virtual) ### 2591589###Speaker###Office Director, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)###FDA (Virtual)###
Speaker: Anne Reid – FDA (Virtual)
### @@@ Rhonda Mecl – FDA (Virtual) ### 2591581###Speaker###Deputy Program Director, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)###FDA (Virtual)###
Speaker: Rhonda Mecl – FDA (Virtual)
###
FDA’s QMSR Implementation Status

Phil Pontikos – Retired, FDA ### 2544315###Moderator######Retired, FDA###
Moderator: Phil Pontikos – Retired, FDA
### @@@ Keisha Thomas, MS, MHS, CQA, RAC – FDA (Virtual) ### 2591601###Speaker###Associate Director for Compliance & Quality, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)###FDA (Virtual)###
Speaker: Keisha Thomas, MS, MHS, CQA, RAC – FDA (Virtual)
### @@@ Karen Masley-Joseph – FDA (Virtual) ### 2591579###Speaker###Senior Advisor, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)###FDA (Virtual)###
Speaker: Karen Masley-Joseph – FDA (Virtual)
###
Fireside Chat with Industry Leaders

Jessica Zeller – Edwards Lifesciences ### 2562430###Moderator###Vice President, Quality, & Regulatory Counsel,###Edwards Lifesciences###
Moderator: Jessica Zeller – Edwards Lifesciences
### @@@ Bill Brodbeck – STERIS Corporation ### 2544305###Speaker###Vice President, Regulatory Affairs###STERIS Corporation###
Speaker: Bill Brodbeck – STERIS Corporation
### @@@ Aaron Dunbar – Boston Scientific ### 2544307###Speaker###Vice President of Quality Systems & Post Market###Boston Scientific###
Speaker: Aaron Dunbar – Boston Scientific
### @@@ Shannon Hoste – Pathway for Patient Health ### 2544316###Speaker###Chief Scientific Officer###Pathway for Patient Health###
Speaker: Shannon Hoste – Pathway for Patient Health
###
Fostering Medical Device Improvement: FDA’s Voluntary Improvement Program

Aaron Dunbar – Boston Scientific ### 2544307###Moderator###Vice President of Quality Systems & Post Market###Boston Scientific###
Moderator: Aaron Dunbar – Boston Scientific
### @@@ Kim Kaplan – ISACA ### 2616090###Speaker###Senior Product Manager###ISACA###
Speaker: Kim Kaplan – ISACA
### @@@ Erin Keith (she/her/hers) – FDA (Virtual) ### 2591576###Speaker###Materials Engineer, Compliance and Quality Program, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)###FDA (Virtual)###
Speaker: Erin Keith (she/her/hers) – FDA (Virtual)
### she/her/hers @@@ Roseanne Leaupepe – Fisher & Paykel Healthcare ### 2633413###Speaker###General Manager – Quality Systems###Fisher & Paykel Healthcare###
Speaker: Roseanne Leaupepe – Fisher & Paykel Healthcare
### @@@ Keisha Thomas, MS, MHS, CQA, RAC – FDA (Virtual) ### 2591601###Speaker###Associate Director for Compliance & Quality, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)###FDA (Virtual)###
Speaker: Keisha Thomas, MS, MHS, CQA, RAC – FDA (Virtual)
###