Eighth Annual FDA Inspections Summit
Product Details
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.
The last 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 – how they think and what they look for. Learn secrets of proving your outsourcing oversight works. Find out what’s just down the FDASIA pike. Take a sneak peek below 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, ORA, FDA, Baltimore District
- Erin McFiren, Consumer Safety Officer, 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
“Excellent speakers throughout entire |
Speakers Include:
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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
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
2013 Sponsors:
Silver Sponsor |
Bronze Sponsor |
For exhibit and sponsorship opportunities at this event, please contact:
Jim Desborough
Phone: +1 (703) 538-7647
Email: jdesborough@fdanews.com
Location:
“So nice that speakers were available |
Bethesda North Marriott Hotel & Conference Center
5701 Marinelli Road
North Bethesda, MD 20852
Toll free: (800) 859-8003 • Tel: +1 (301) 822-9200
www.bethesdanorthmarriott.com
Room rate: $209 plus 13% tax
Reservation cut-off: Oct. 1, 2013
Complete Summit
(Pre-Conference Wednesday, Oct. 23; Full Conference Thursday-Friday, Oct. 24-25)
Tuition includes the preconference workshop, all conference sessions, conference and workshop materials, two breakfasts, one luncheon, one reception, and refreshments.
Full Conference Only (Thursday-Friday, Oct. 24-25)
Tuition includes all conference presentations, conference materials, two breakfasts, one luncheon, one reception, and refreshments.
Pre-Conference Workshop Only (Wednesday afternoon, Oct. 23)
Tuition includes the preconference workshop, workshop materials, and refreshments.
Registration and Conference Fees:
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VIP Club Fee
Until Sept. 27, 2013 |
Regular Fee
Sept. 28 –Oct. 23, 2013 |
Complete Summit
|
|
$1,997
|
Conference Only
|
|
$1,697
|
Preconference Workshop
|
|
$597
|
LiveStreaming
|
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$1,497
|
Send Your Team for Maximum Benefit
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 |