Drug and Device Recalls Summit

Conference

Drug and Device
Recalls Summit

Bethesda, MD • April 29-30, 2014

 

Meet Your Conference Chairman


 

David Elder is Vice President of Strategic Compliance Services at PAREXEL Consulting. He served as the Director of the Office of Regional Operations (ORO) within the Office of Regulatory Affairs (ORA), where he managed a team of professionals working around the globe to ensure that regulated products met the FDA’s standards, rules and regulations.  Previously, Mr. Elder was Director of the Office of Enforcement within ORA. Prior to this position, he served in the FDA’s New England District Office as an investigator, compliance officer and as Director of the Compliance Branch.

During his 23 year tenure with the FDA, Mr. Elder was involved in domestic and foreign inspections, recalls and emergencies, and compliance actions involving hundreds of situations.  He testified in federal court and before Congress, initiated and approved enforcement actions, and represented the FDA during national media events. As Office Director for both Enforcement and Regional Operations, he was a principal advisor to the Associate Commissioner of Regulatory Affairs at the FDA.

 

Conference Speakers
 

  • Heath Rushing, Principal Consultant, Adsurgo LLC
  • Julianne McCullough, Recall Coordinator, Philadelphia District Office, ORA, FDA (invited)
  • Kevin Morrow, Recall Coordinator, Baltimore District Office, ORA, FDA (invited)
  • Ronny Brown, Chief, Recall Branch, Division of Risk Management Operations, Office of Compliance, CDRH, FDA (invited)
  • Marialuisa (“ML”) Gallozzi, Partner, Covington & Burling
  • Suzan Charlton, Special Counsel, Covington & Burling
  • James Johnson, Associate, Hogan Lovells; former Associate Chief Counsel in the FDA’s Office of the Chief Counsel
  • Sunni Churchill, Senior Director, Regulatory Affairs, US Generics, Teva Pharmaceuticals
  • Joe Falvo, Senior Manager, Post Market Risk Management , Ortho Clinical Diagnostics
  • Rita Hoffman, Principal Consultant, Regs & Recall Strategies, LLC; former Branch Chief, Recalls, CDRH, FDA
  • Todd Halpern, Assistant General Counsel, Regulatory Law, Pfizer
  • Mary Swift, Senior Manager, Regulatory Affairs, Terumo Cardiovascular Systems
  • Fayyaz Memon, Vice President, Regulatory Affairs and Quality Assurance, PrimeraDX, Inc.