2015 FDA Inspections Summit Complete Archive


The 10th Annual Inspections Summit is over, but that doesn’t mean you can’t benefit from the information that was presented. Order the complete archive and get all your questions answered.

This year’s Summit included sessions on

  • The FDA’s mutual inspection program with Europe …
  • Latest on the FDA’s Quality Metrics Initiative…
  • A day in the life of an FDA field investigator: Current and former investigators explain what they look for — and why — and what’s on the horizon …
  • Data Integrity: Is your company at risk …
  • Update: The International Medical Device Regulators Forum’s single-audit program …
  • Curbing 483s: Newest and most successful “learning” methods …
  • And much more!

With twin tracks for drug/biologics and device manufacturers, you’ll discover sessions and panels for every FDA-regulated company.

  • For drug and biologics makers, there is a panel on understanding OPQ’s new inspection and reporting plan and organizational structure
  • Devicemakers will hear first-hand progress on the Medical Device Single Audit Program with lessons learned from the pilot program. Devicemakers will also learn what to expect from an audit and how multiple sites should be audited.
  • And everyone will be on the edge of their seats as experts from within and outside the agency pass along proven secrets to FDA success.

This year’s Summit included the following FDA speakers:

  • Dr. Lawrence Yu, Deputy Director, Office Product Quality, CDER, FDA
  • Karthik Iyer, Acting Branch Chief, Quality Intelligence Branch, OC, OPQ, CDER, FDA
  • Marc-Henri Winter, Staff Fellow, Division of International Compliance Operations, OC, CDRH, FDA
  • Phil Pontikos, CSO, National Device Expert, OMPTO, ORA, FDA, Columbus, OH
  • CAPT Cynthia Harris, Bioresearch Monitoring Specialist, ORA, FDA, Baltimore District Office
  • Marc Neubauer, CSO, Medical Device Specialist, ORA, FDA, Baltimore District
  • Dr. Lawrence Yu, Deputy Director, Office Product Quality, CDER, FDA
  • CDR Helen Y. Saccone, PharmD, Senior Advisor, Global Regulatory Policy, Office of Global Regulatory Operations and Policy, FDA
  • Douglas Stearns, Director, Office of Enforcement and Import Operations, ORA, FDA

Plus we had many former FDA insiders among our private-sector panelists:

  • John Avellanet, Managing Director and Principal, Cerulean Associates LLC
  • Denyse Baker, Senior Advisor, Scientific and Regulatory Affairs, PDA; former Quality Assurance Specialist, Office of New Drug Quality Assessment
  • Dr. Nuala Calnan, Regulatory Science Research Fellow, Pharmaceutical Regulatory Science Team, School of Chemical & Pharmaceutical Sciences, Dublin Institute of Technology
  • David Chesney, Vice President, Strategic Compliance Services, PAREXEL Consulting
  • John C. (Jack) Garvey, Principal, CEO, Compliance Architects LLC
  • Roberta Goode, President and CEO, Goode Compliance International
  • Connie Hoy, Senior VP of Regulatory Affairs, Cynosure
  • Julie Larsen, Senior Partner, Director Inspection Readiness Services, BioTeknica
  • Dr. Beverly Lorell, Senior Medical and Policy Advisor, FDA & Life Sciences Practice Group, King & Spalding
  • Dina Maines, Managing Consultant, Compliance Architects LLC
  • Elaine Messa, President, NSF Health Sciences, Medical Device Consulting; former director of the Los Angeles District, FDA
  • Steve Niedelman, Lead Quality Systems and Compliance Consultant, King and Spalding, former FDA Deputy Associate Commissioner for Regulatory Operations
  • Dan O’Leary, President, Ombu Enterprises
  • Vicky Stoakes, President, IntegRx, Inc.; former FDA Chemist, ACNA and Investigator, Atlanta District Office Drug Cadre
  • Dr. Louis W. Yu, Executive Vice President, Global Quality & Compliance, Perrigo Company plc

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