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WASHINGTON DC, USA -- HEALTH CARE UPDATE NEWS SERVICE™ -- OCTOBER 2, 2014: It's time for the 9th Annual FDA Inspections Summit, focusing on inspectional readiness. Want to pass your next inspection with flying colors? Then read this letter now.
What's the state of FDA's Quality Metrics Initiative? When will you have to start collecting data? What will you have to track?
And where does the agency stand on the reorganization of its inspectional operations? What will that mean for you?
Get those questions answered and many more, at the 9th Annual FDA Inspection Summit, sponsored by FDAnews.
With twin tracks for drug/biologics and device manufacturers, you'll discover sessions and panels for every FDA-regulated company.
- For drug and biologics makers, we've scheduled a standout panel on the 10 best -- and 10 worst -- things to do during a drug or biologics inspection.
- Devicemakers will hear FDA investigator Lori Lawless spell out the intricacies of QSIT, with emphasis on making sure your seven subsystems are in compliance and properly linked.
- And everyone will be on the edge of their seats as experts from within and outside the agency pass along proven secrets to FDA success.
This year we're in downtown Bethesda MD. Close to the FDA's headquarters.
But no need to go there... nor even leave the conference hotel. The people you came to see are right there in the room, rubbing elbows. We've invited multiple FDAers including --
- Kimberly Trautman, Associate Director, International Affairs, Medical Device International Quality Systems Expert, Office of the Center Director, CDRH
- Dr. Neil Stiber, Operations Research Analyst, Office of Strategic Programs, CDER, FDA
- Lori Lawless, SCSO, Medical Device Specialist, ORA, Baltimore District
- Marc Neubauer, CSO, Medical Device Specialist, ORA, FDA, Baltimore District
- Cynthia Harris, SRO, Medical Device/Bioresearch Monitor, ORA, FDA, Baltimore District
- Phil Pontikos, CSO, National Device Expert, OMPTO, ORA, FDA, Columbus, OH
Plus we have also invited many former FDA insiders among our private-sector panelists --
- Former Los Angeles District Director Elaine Messa, President, Medical Devices, NSF Health Sciences
- Former FDA investigator Vicky Stoakes, now President, IntegRx
- Former FDA Deputy Associate Commissioner for Regulatory Operations, Steve Niedelman, now Lead Quality Systems and Compliance Consultant, King and Spalding
These are just a few of the many speakers we will have at this year's Inspection Summit. Register today.
Over two days, you'll discover solutions to the sort of problems that keep you up at night --
- Latest on the FDA's Quality Metrics Initiative...
- A day in the life of an FDA field investigator: Current and former investigators explain what they look for -- and why -- and what's on the horizon...
- CBER inspectional findings: A review of recent Warning Letters...
- Update: The International Medical Device Regulators Forum's single-audit program...
- Curbing 483s: Newest and most successful "learning" methods...
- And much more!
For complete conference schedule, click here.
"The panel discussion with current and prior FDA investigators was a great learning experience. Loved the case study presentation - live examples to learn from."
- Jillian Wirth, Manager-QA, Ashfield Healthcare LLC
The official conference kicks off Thursday morning, Oct. 23, with complimentary continental breakfast and get-acquainted session, followed by 1½ days filled with sessions, workshops and socializing.
And be sure to sign up for the special Pre-Conference Afternoon Workshops. You have two to choose from --
- Flawless FDA Drug and Biologics Inspection Handling and Response
- No More 483s - QSIT Secrets to Assure Clean Device Inspections
"Usually there are only a few standout speakers, but there were excellent speakers throughout this entire conference."
- Karen Vasquez, Regulatory Analyst, Boehringer Ingelheim Roxane
These four-hour pre-conference sessions run concurrently on Wednesday afternoon, Oct. 22.
Complete pre-conference session details and registration -- click here.
The Doubletree Hotel is ideally located in downtown Bethesda, with fine dining and entertainment in easy walking distance. Or hop on the Metro subway and be anywhere inside or outside the Beltway in mere minutes.
The conference adjourns at noon Friday, Oct. 24, leaving you plenty of leeway to arrive home at a reasonable hour. But consider lingering through the weekend. Washington in late October is a dream of blazing autumn color, with world-class attractions from the Smithsonian museums to shopping at Tysons Corner and Tysons Galleria. Your special low conference hotel rates remain good through a Monday morning checkout.
LOCATION
Bethesda Doubletree Hotel
8120 Wisconsin Ave.
Bethesda, MD 20814
Toll free: (800) 560-7753 • Tel: +1 (301) 652-2000
www.doubletreebethesda.com
Special Conference Room Rate: $215 plus 13% tax
Reservation cut-off: Tuesday, Sept. 30, 2014
REGISTRATION AND CONFERENCE FEES
TEAM DISCOUNTS
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. Call +1 (703) 538-7600 for details.
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.
EXHIBIT AND SPONSORSHIP OPPORTUNITIES
For exhibit and sponsorship opportunities at this event, please contact:
Jim Desborough
Phone: +1 (703) 538-7642
Email: jdesborough@fdanews.com
COMPLETE SUMMIT
(Pre-Conference Wednesday, Oct. 22; Full Conference Thursday-Friday, Oct. 23-24)
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. 23-24)
Tuition includes all conference presentations, conference materials, two breakfasts, one luncheon, one reception, and refreshments.
PRE-CONFERENCE WORKSHOP ONLY
(Wednesday afternoon, Oct. 22)
Tuition includes the preconference workshop, workshop materials, and refreshments.
LIVESTREAMING
Not free to travel but still want to participate? You're covered! The 9th Annual FDA Inspections Summit will be streamed live! Participate from the comfort of desktop, conference room or auditorium -- or even your mobile device. You avoid all the hassles of travel... plus, as many participants as you like may participate simultaneously at no additional charge, as long as they're at the same location!
- Watch the live stream and view presentation materials in real time...
- Easily download all presentation materials and supporting documents...
- Ask questions via email in real time...
- BONUS: Your streaming-video registration includes six months' FREE access to archived session recordings following the conference!
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FEATURED SPEAKERS
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KIMBERLY TRAUTMAN
Associate Director, International Affairs, Medical Device International Quality Systems Expert, Office of the Center Director, CDRH, FDA
DR. NEIL STIBER
Operations Research Analyst, Office of Strategic Programs, CDER, FDA
LORI LAWLESS, SCSO
Medical Device Specialist, ORA, FDA, Baltimore District
MARC NEUBAUER, CSO
Medical Device Specialist, ORA, FDA, Baltimore District
CAPT. CYNTHIA HARRIS, SRO
Medical Device/Bioresearch Monitor, ORA, FDA, Baltimore District
PHIL PONTIKOS, CSO
National Device Expert, OMPTO, ORA, FDA, Columbus, OH
STEVE NIEDELMAN
Lead Quality Systems and Compliance Consultant, King and Spalding, former FDA Deputy Associate Commissioner for Regulatory Operations
ELAINE MESSA
Executive Vice President of the Medical Device Practice, NSF Health Sciences; former Director of the Los Angeles District, FDA
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WHO SHOULD ATTEND?
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- Executive Management
- Regulatory Affairs
- Quality Assurance/Quality Control
- Legal and Compliance Officers
- Clinical Research Directors
- Consultants/Service Providers
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EASY WAYS TO REGISTER
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Please mention priority code 14PG.
- Enroll online.
- Call toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600.
- Mail your check to: FDAnews, 300 N. Washington St., Suite 200, Falls Church, VA 22046-3431.
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SILVER SPONSOR:
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