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Last updated on April 24, 2014 at 21:24 EDT

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

August 23, 2013

FALLS CHURCH, Va., Aug. 23, 2013 /PRNewswire-iReach/ — Eighth Annual FDA Inspections Summit

New Powers, New Enforcement Posture, New Challenges

**Presented by FDAnews**

Oct. 23-25, 2013 – Bethesda, MD

www.fdanews.com/FDAInspections

(Photo: http://photos.prnewswire.com/prnh/20130823/MN68857)

For the first time, FDA officials can detain drug products they believe are adulterated or misbranded. They can detain the drug for up to 20 days, and 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.

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’ 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 (invited)
    --  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

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.

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/Service Providers

Register Now

CONFERENCE DETAILS

Eighth Annual FDA Inspections Summit

New Powers, New Enforcement Posture, New Challenges

**Presented by FDAnews**

Oct. 23-25, 2013 – Bethesda, MD

www.fdanews.com/FDAInspections

TUITION:

Early Bird (available until Sept. 23, 2013): $1,797

Regular Rate (after Sept. 23, 2013): $1,997

4 Easy Ways to Register

Online: www.fdanews.com/FDAInspections

By phone: 888-838-5578 or 703-538-7600

Fax: 703-538-7676

Mail to: FDAnews

300 N Washington St

Ste 200

Falls Church, VA USA 22046-3431

Media Contact: Jeff Grizzel, FDAnews, 703-538-7600, jgrizzel@fdanews.com

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SOURCE FDAnews


Source: PR Newswire