Welcome!

News Feed Item

FDAnews Announces: 9th Annual FDA Inspections Summit, Oct. 22-24, 2014, Bethesda, MD

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

9th Annual FDA Inspections Summit
**Presented by FDAnews**
Oct. 22-24, 2014Bethesda, 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, 2014Bethesda, 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, [email protected]

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

SOURCE FDAnews

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
As DevOps methodologies expand their reach across the enterprise, organizations face the daunting challenge of adapting related cloud strategies to ensure optimal alignment, from managing complexity to ensuring proper governance. How can culture, automation, legacy apps and even budget be reexamined to enable this ongoing shift within the modern software factory?
DXWorldEXPO LLC, the producer of the world's most influential technology conferences and trade shows has announced the 22nd International CloudEXPO | DXWorldEXPO "Early Bird Registration" is now open. Register for Full Conference "Gold Pass" ▸ Here (Expo Hall ▸ Here)
Evan Kirstel is an internationally recognized thought leader and social media influencer in IoT (#1 in 2017), Cloud, Data Security (2016), Health Tech (#9 in 2017), Digital Health (#6 in 2016), B2B Marketing (#5 in 2015), AI, Smart Home, Digital (2017), IIoT (#1 in 2017) and Telecom/Wireless/5G. His connections are a "Who's Who" in these technologies, He is in the top 10 most mentioned/re-tweeted by CMOs and CIOs (2016) and have been recently named 5th most influential B2B marketeer in the US. H...
Enterprises are moving to the cloud faster than most of us in security expected. CIOs are going from 0 to 100 in cloud adoption and leaving security teams in the dust. Once cloud is part of an enterprise stack, it’s unclear who has responsibility for the protection of applications, services, and data. When cloud breaches occur, whether active compromise or a publicly accessible database, the blame must fall on both service providers and users. In his session at 21st Cloud Expo, Ben Johnson, C...
In his session at 21st Cloud Expo, James Henry, Co-CEO/CTO of Calgary Scientific Inc., introduced you to the challenges, solutions and benefits of training AI systems to solve visual problems with an emphasis on improving AIs with continuous training in the field. He explored applications in several industries and discussed technologies that allow the deployment of advanced visualization solutions to the cloud.
Charles Araujo is an industry analyst, internationally recognized authority on the Digital Enterprise and author of The Quantum Age of IT: Why Everything You Know About IT is About to Change. As Principal Analyst with Intellyx, he writes, speaks and advises organizations on how to navigate through this time of disruption. He is also the founder of The Institute for Digital Transformation and a sought after keynote speaker. He has been a regular contributor to both InformationWeek and CIO Insight...
For better or worse, DevOps has gone mainstream. All doubt was removed when IBM and HP threw up their respective DevOps microsites. Where are we on the hype cycle? It's hard to say for sure but there's a feeling we're heading for the "Peak of Inflated Expectations." What does this mean for the enterprise? Should they avoid DevOps? Definitely not. Should they be cautious though? Absolutely. The truth is that DevOps and the enterprise are at best strange bedfellows. The movement has its roots in t...
Your homes and cars can be automated and self-serviced. Why can't your storage? From simply asking questions to analyze and troubleshoot your infrastructure, to provisioning storage with snapshots, recovery and replication, your wildest sci-fi dream has come true. In his session at @DevOpsSummit at 20th Cloud Expo, Dan Florea, Director of Product Management at Tintri, provided a ChatOps demo where you can talk to your storage and manage it from anywhere, through Slack and similar services with...
Join IBM November 1 at 21st Cloud Expo at the Santa Clara Convention Center in Santa Clara, CA, and learn how IBM Watson can bring cognitive services and AI to intelligent, unmanned systems. Cognitive analysis impacts today’s systems with unparalleled ability that were previously available only to manned, back-end operations. Thanks to cloud processing, IBM Watson can bring cognitive services and AI to intelligent, unmanned systems. Imagine a robot vacuum that becomes your personal assistant tha...
Containers are rapidly finding their way into enterprise data centers, but change is difficult. How do enterprises transform their architecture with technologies like containers without losing the reliable components of their current solutions? In his session at @DevOpsSummit at 21st Cloud Expo, Tony Campbell, Director, Educational Services at CoreOS, will explore the challenges organizations are facing today as they move to containers and go over how Kubernetes applications can deploy with lega...
In their session at @DevOpsSummit at 21st Cloud Expo, Michael Berman, VP Engineering at TidalScale, and Ivo Jimenez, Engineer at TidalScale, will describe how automating tests in TidalScale is easy thanks to WaveRunner. They will show how they use WaveRunner, Jenkins, and Docker to have agile delivery of TidalScale. Michael Berman is VP Engineering at TidalScale. TidalScale is developing a scale up compute and resource architecture for customers to perform big data exploration and real time anal...
"MobiDev is a software development company and we do complex, custom software development for everybody from entrepreneurs to large enterprises," explained Alan Winters, U.S. Head of Business Development at MobiDev, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
I think DevOps is now a rambunctious teenager - it's starting to get a mind of its own, wanting to get its own things but it still needs some adult supervision," explained Thomas Hooker, VP of marketing at CollabNet, in this SYS-CON.tv interview at DevOps Summit at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"With Digital Experience Monitoring what used to be a simple visit to a web page has exploded into app on phones, data from social media feeds, competitive benchmarking - these are all components that are only available because of some type of digital asset," explained Leo Vasiliou, Director of Web Performance Engineering at Catchpoint Systems, in this SYS-CON.tv interview at DevOps Summit at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
The “Digital Era” is forcing us to engage with new methods to build, operate and maintain applications. This transformation also implies an evolution to more and more intelligent applications to better engage with the customers, while creating significant market differentiators. In both cases, the cloud has become a key enabler to embrace this digital revolution. So, moving to the cloud is no longer the question; the new questions are HOW and WHEN. To make this equation even more complex, most ...