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:2/21/2017)... BANGALORE , February 21, 2017 ... Appropriate Technology for Adoption by Plastic Industry  ... STEER, ... and functionalise materials in the fields of plastics, pharmaceuticals, ... collaboration with Merck KGaA, Darmstadt, Germany ...
(Date:2/21/2017)... 21, 2017 Research and Markets has announced ... Trends - Industry Forecast to 2025" report to their offering. ... The Global Apheresis ... 12.3% over the next decade to reach approximately $4.5 billion by ... and forecasts for all the given segments on global as well ...
(Date:2/21/2017)... , February 21, 2017 According to a new ... Systems (Surgical Robots, Rehabilitation Robots, Hospital Robots, Non-invasive Surgery Robots)), Application (Orthopedic, Laparoscopy, ... Continue Reading ... MarketsandMarkets Logo ... This report studies the global ...
Breaking Medicine Technology:
(Date:2/21/2017)... Fort Worth, TX (PRWEB) , ... February 21, 2017 , ... ... planning assistance to communities in and around Tarrant County, is embarking on a six ... to research cures and treatments for cancer. , Cancer is one of the deadliest ...
(Date:2/21/2017)... ... February 21, 2017 , ... American Veterinarian™, the ... will be launching its first bi-monthly issue of 2017 in February. The inaugural ... management, and One Health. , In making the announcement, American Veterinarian™ Publisher ...
(Date:2/21/2017)... ... February 21, 2017 , ... ... during Black History Month (officially African American History Month ). ... American society of a diverse race of people, but also the opportunity to ...
(Date:2/21/2017)... ... February 21, 2017 , ... HIMSS ... The connected care demonstration spanned multiple health information systems including OpenEMR, EMRDirect, ... of providers have no Health Information Exchange outside of faxing. Medal’s innovative technology ...
(Date:2/21/2017)... ... 2017 , ... A February 6 article on Healio describes a ... that the treatments have led to significant improvements in weight loss and other health ... also noted very few problematic results relating to the treatment. Beverly Hills Physicians (BHP) ...
Breaking Medicine News(10 mins):