Navigation Links
FDAnews Announces: 9th Annual FDA Inspections Summit, Oct. 22-24, 2014, Bethesda, MD
Date:8/25/2014

FALLS CHURCH, Va., Aug. 25, 2014 /PRNewswire-iReach/ --

9th Annual FDA Inspections Summit
**Presented by FDAnews**
Oct. 22-24, 2014 – Bethesda, MD
www.fdanews.com/9thFDAInspectionsSummit

Photo - http://photos.prnewswire.com/prnh/20140822/138921

What's the state of FDA's Quality Metrics Initiative? When will drug and devicemakers have to start collecting data? What will they have to track?

And where does the agency stand on the reorganization of its inspectional operations? What will that mean to the industry?

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, attendees will discover sessions and panels for every FDA-regulated company.

  • For drug and biologics makers, there's 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 the seven subsystems are in compliance and properly linked.
  • And all attendees will be on the edge of their seats as experts from within and outside the agency pass along proven secrets to FDA success.

The people attendees want to see are right there in the room, rubbing elbows. Multiple FDAers have been invited 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
  • Kirk Sooter, District Director, Philadelphia District Office, ORA, FDA
  • Lori Lawless, SCSO, Medical Device Specialist, ORA, Baltimore District
  • Marc Neubauer, CSO, Medical Device Specialist, ORA, FDA, Baltimore District
  • Capt. Cynthia Harris, SRO, Medical Device/Bioresearch Monitor, ORA, FDA, Baltimore District

Plus many former FDA insiders have been invited among the private-sector panelists:

  • Former Los Angeles District Director Elaine Messa, head of the Medical Device Practice at Becker & Associates Consulting
  • 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 at this year's Inspection Summit. 

Over two days, attendees will discover solutions to the sort of problems that keep them 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

Conference Details:
9th Annual FDA Inspections Summit
**Presented by FDAnews**
Oct. 22-24, 2014 – Bethesda, MD
www.fdanews.com/9thFDAInspectionsSummit

Tuition:
Early Bird Registration (until Sept. 19, 2014): Complete Summit $1,797
Regular Registration (Sept. 20, 2014 on): Complete Summit $1,997
Additional pricing options are available online.

Easy Ways to Register:
Online:  www.fdanews.com/9thFDAInspectionsSummit
By phone: 888-838-5578 or 703-538-7600

About FDAnews
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Media Contact: Michelle Butler, FDAnews, 703-538-7665, mbutler@fdanews.com

News distributed by PR Newswire iReach: https://ireach.prnewswire.com


'/>"/>
SOURCE FDAnews
Copyright©2014 PR Newswire.
All rights reserved

Related medicine technology :

1. FDAnews Announces Medical Device Mobile Apps Virtual Conference - Oct. 3, 2013
2. FDAnews Announces The Insiders Guide to Supplier Quality Success DVD
3. FDAnews Announces Leading the Climb: Seven Essentials of GMP Workshop
4. FDAnews Announces Medical Device Risk Management Conference, July 11-12, 2013, Boston, MA
5. FDAnews Announces Clinical Quality Assurance Workshop
6. FDAnews announces Biopharmaceutical Good Distribution Practices Summit
7. FDAnews announces Fifth Annual Risk Management & Drug Safety Summit
8. FDAnews announces Third Annual Pharmaceutical Labeling Summit
9. FDAnews Announces Medical Device Mobile Apps Virtual Conference
10. FDAnews announces Fourth Annual Supplier Quality Congress
11. AbbVie Cystic Fibrosis Scholarship Program Awards 40 Student Scholars With Annual Academic Awards
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/11/2017)... founder of Echenberg Institute, is announcing a new safe and effective at-home ... and other painful pelvic pain conditions such as pelvic floor dysfunction, vulvodynia, ... ... ... start-up company, VuVatech LLC, fills a void in the women,s wellness market ...
(Date:7/10/2017)... COLUMBIA, S.C. , July 10, 2017 /PRNewswire/ ... product purchasing and patient support services organization serving ... announced today the launch of four significant, value-added ... into market insights, better manage reimbursement and improve ... Ig and factor therapies. ...
(Date:7/5/2017)... 5, 2017 Wolfmet 3D  printed tungsten collimator manufactured by ... and manufacturing combine to progress molecular radiotherapy imaging. ... are unable to accurately quantify the radiation absorbed by those ... the success of this radiotherapy treatment has been available — ... ...
Breaking Medicine Technology:
(Date:7/25/2017)... ... 25, 2017 , ... Creative Pharmacist and ... the Pharmacist eCare Plan to Computer-Rx pharmacies through the STRAND platform. ... to develop the Pharmacist eCare Plan, a shared document detailing a patient’s current ...
(Date:7/25/2017)... ... July 25, 2017 , ... Dr. Gina Negrette, a skilled ... than a decade of experience in psychiatry, treating clients in diverse settings, including ... disorders, psychotic and manic conditions, as well as those who were fighting simply ...
(Date:7/24/2017)... , ... July 24, 2017 ... ... Director,      (407) 916-7235, kklaproth(at)robinsmorton(dot)com , Robins & Morton, Perkins ... to celebrate the structural topping out of the new Destination Medical Building ...
(Date:7/24/2017)... MD (PRWEB) , ... July 24, 2017 , ... ... Public Schools (MCPS) have partnered together for a unique opportunity that helps high school ... mission of “Removing Barriers, Creating Opportunities.” Horizon Goodwill will host over 20 ...
(Date:7/24/2017)... CLARA, CA (PRWEB) , ... July 24, 2017 , ... ... and financial organizations, today announced it has partnered with WALLIX to expand ... Special Publication 800-171 . , There are a number of ways to address the ...
Breaking Medicine News(10 mins):