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Follow on Google News | Eighth Annual FDA Inspections Summit: Early Bird Registration Ends Sept. 20Eighth Annual FDA Inspections Summit New Powers, New Enforcement Posture, New Challenges **Presented by FDAnews** Oct. 23-25, 2013 – Bethesda, MD www.fdanews.com/FDAInspectionsSummitPR1
By: FDAnews Plus, FDASIA allows the agency to register importers and directs it to establish Good Importer Practice (GIP) regulations. We’ve 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 your facility without your 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 your operations. Take a rare opportunity to pick FDA investigators’ 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, ORA, 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 (http://www.fdanews.com/ Who Will Benefit 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/ CONFERENCE DETAILS Eighth Annual FDA Inspections Summit New Powers, New Enforcement Posture, New Challenges **Presented by FDAnews** Oct. 23-25, 2013 – Bethesda, MD http://www.fdanews.com/ TUITION: Early Bird (available until Sept. 20, 2013): $1,797 Regular Rate (after Sept. 20, 2013): $1,997 Easy Ways to Register Online: http://www.fdanews.com/ By phone: 888-838-5578 or 703-538-7600 End
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