Eighth Annual FDA Inspections Summit

$1,617.00
Quantity Discounts
1 - 9999
$1,617.00
1 - 9999
$1,374.00
1 - 9999
$483.00
1 - 9999
$1,167.00
1 - 9999
$1,617.00
1 - 9999
$1,374.00
1 - 9999
$483.00
1 - 9999
$1,167.00

 
 
 

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
conference ... Breakout sessions focus
on my particular interest/concern ...
Cost/value was appropriate.”
— Karen Vasquez, Regulatory Analyst,
Boehringer Ingelheim Roxane Inc.

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

View Speaker Bios

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
after and throughout the Summit to
answer people’s questions.”
— Sheri Kuss, Sr. Training Mgr.-
Qualitative Operations, Sanofi-Aventis

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:

 
VIP Club Fee
Until Sept. 27, 2013
Regular Fee
Sept. 28 –Oct. 23, 2013
Complete Summit
$1,797 $1,617
$1,997
Conference Only
$1,527 $1,374
$1,697
Preconference Workshop
$537 $483
$597
LiveStreaming
$1,297 $1,167
$1,497

Send Your Team for Maximum Benefit
Get your team up to speed!

Significant tuition discounts are available for teams of two or
more from the same company. You must register at the same time and
provide a single payment to take advantage of the discount. Register below
by clicking on add to cart and then change your quantity in the shopping cart.
The discount will be calculated automatically.

2-4 attendees – 10%
7-9 attendees – 20%
5-6 attendees – 15%
10+ attendees – 25%

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600
globally with any questions.

Payment is required by the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to FDAnews.

Or, register by phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600.

FDAnews offers a variety of webinars and conferences to keep you and your staff current on today’s most important regulatory, legislative and business issues. Click here to view a complete list of the topics available and register today.

Cancellations/Substitutions

Written cancellations received at least 21 calendar days prior to the start date of the event will receive a refund less a $200 administration fee. No cancellations will be accepted, nor refunds issued, within 21 calendar days from the start date of the event. A credit for the amount paid may be transferred to any future FDAnews event. Substitutions may be made at any time. No-shows will be charged the full amount. In the event that FDAnews cancels the event, FDAnews is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.