FDAnews Announces: Eighth Annual FDA Inspections Summit — FDAers Featured in All-Star Speaking Roster

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This Summit will bring together regulators, drug and device makers and industry inspection experts. They will debate and discuss the challenges they will face over the coming year and proven strategies to tackle them.

Eighth Annual FDA Inspections Summit Oct. 23-25, 2013, Bethesda, MD

FDAnews Eighth Annual FDA Inspections Summit

“Excellent speakers throughout entireconference ... Breakout sessions focuson my particular interest/concern ...Cost/value was appropriate.”— Regulatory Analyst,Boehringer Ingelheim Roxane Inc.

On July 12, the FDA moved to close a glaring gap in the agency’s import powers, issuing a proposed rule that grants detention authority for drugs. For the first time, FDA officials can detain drug products they believe are adulterated or misbranded. Under the proposed rule, an inspector can detain a drug for up to 20 days if he or she believes it is adulterated or misbranded. A drug importer has just 5 days to appeal the detention order after receiving it.

Plus, FDASIA allows the agency to register importers and directs it to establish Good Importer Practice (GIP) regulations.

FDAnews has invited John Taylor III, Counselor to the Commissioner and Acting Deputy Commissioner for Global Regulatory Operations and Policy at FDA, to provide details at the Eighth Annual FDA Inspections Summit.

The past few months have seen a sharp increase in FDA’s enforcement powers: the ability to detain drug products at the border, allowing investigators to take photos in a facility without approval and new registration requirements.

Coupled with increasingly LONG and very DETAILED Form 483s and warning letters, it’s enough to make any quality or compliance professional a little nervous.

Today’s inspectors are a breed unto themselves — many have worked in industry and know where traps are hiding in your plant or its documentation. They are highly educated, clear-headed and are well trained to look into every aspect of a facilities operations.

Take a rare opportunity to pick FDA investigators’ brains — learn how they think and what they look for. Discover secrets of proving your outsourcing oversight works. Find out what’s just down the FDASIA pike. Take a sneak peek at top-notch speakers:

FDA Speakers Include:

  • John Taylor III, Counselor to the Commissioner and Acting Deputy Commissioner for Global Regulatory Operations and Policy, OC, FDA (invited)
  • David Glasgow, Director, Division of Domestic Field Investigations, ORA, FDA (invited)
  • Diane Amador Toro, District Director, ORA, FDA, Parsippany District
  • Elizabeth Dickinson, Chief Counsel, OC, FDA (invited)
  • Rick Friedman, Associate Director, Office of Manufacturing & Product Quality, CDER, FDA (invited)
  • Brian Hasselbalch, Acting Associate Director, Policy and Communication, OMPQ CDER, FDA (invited)
  • Grace McNally, Senior Policy Advisor, OC, CDER, FDA (invited)
  • Dr. Leslie Ball, Assistant Commissioner for International Programs, Deputy Director, Office of International Programs, Office of Global Regulatory Operations and Policy, ORA, FDA
  • Kimberly Trautman, Associate Director, International Affairs, Medical Device International Quality Systems Expert, Office of the Center Director, CDRH, FDA (invited)
  • Lori Lawless, SCSO, Medical Device Specialist, ORA, FDA, Baltimore District
  • Rachel Harrington, CSO, Drug Specialist, FDA, Baltimore District
  • Erin McFiren, CSO, Medical Device Specialist, ORA, FDA, Baltimore District

Former FDA Speakers Include:

  • Elaine Messa, Executive Vice President of the Medical Device Practice, Becker & Associates Consulting; former Director of the Los Angeles District, FDA
  • Larry Spears, Director, Deloitte & Touche LLP, former Deputy Director for Regulatory Affairs at CDRH, FDA
  • David Chesney, Vice President and Practice Lead, Strategic Compliance Services, PAREXEL Consulting; former FDA District Director for the San Francisco office
  • Tim Wells, President, QualityHub; former Team Leader for the QSIT Project, CDRH, FDA

Other Speakers Include:

  • Barbara Immel, President, Immel Resource LLC (Chairperson)
  • Frederick Branding, Principal, Olsson Frank & Weeda
  • Gilda D’Incerti, CEO, Pharma Quality Europe
  • John Avellanet, Managing Director & Principal, Cerulean Associates LLC
  • Marie McDonald, Senior Director, Quality & Compliance Consulting, Quintiles
  • Connie Hoy, Vice President, Global Regulatory Affairs, Palomar Medical Technologies
  • Dr. Ibim Tariah, Technical Director, BSI Healthcare Solutions

For complete pre-conference and conference schedules, click here.

Every FDA-regulated drug, device, biologics or clinical trial company will find something of value in the Eighth Annual FDA Inspections Summit. Here’s a suggested list of potential participants from your organization:

  • Executive Management
  • Regulatory Affairs
  • Quality Assurance/Quality Control
  • Legal and Compliance Officers
  • Clinical Research Directors
  • Consultants/Service Providers

Eighth Annual FDA Inspections Summit
New Powers, New Enforcement Posture, New Challenges
**Presented by FDAnews**
Oct. 23-25, 2013 – Bethesda, MD

Complete Summit: $1,997

Online: http://www.fdanews.com/InspectionsSummit2013
By phone: 888-838-5578 or 703-538-7600

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Michelle Butler
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