Welcome!

News Feed Item

FDAnews Confirms Speaker Dr. Maria Isabel Tejero del Rio, Office of Compliance, CDRH, FDA for Device Supplier Controls Virtual Conference, Feb. 26

FALLS CHURCH, Va., Feb. 21, 2014 /PRNewswire-iReach/ -- Device Supplier Controls
Does the FDA's Next 483 Have Your Name on It?
**FDAnews Virtual Conference**
Feb. 26, 201410:00 a.m.4:00 p.m. EST
www.fdanews.com/DeviceSupplierQualityNewSpeakerdelRio  

(Photo: http://photos.prnewswire.com/prnh/20140221/MN68981)

Dr. Tejero de Rio, Lead Consumer Safety Officer, Division of Manufacturing and Quality, Office of Compliance, CDRH, FDA is presenting the opening Keynote at FDAnews' Device Supplier Controls Virtual Conference on Feb. 26.

Opening Keynote: Supplier Controls — FDA Medical Device Requirements
The FDA has been actively focusing on the protection and integrity of contract manufacturers and suppliers for medical devices. Understanding the FDA's approach is essential to ensuring compliance and avoiding problems. This session will take attendees through the latest FDA policies and processes.

Attendees will learn:

  • Common contract manufacturer and supplier issues the FDA uncovers in medical device inspections and how firms can avoid them
  • How suppliers, contractors and consultants should meet the requirements established by the finished device manufacturer
  • After the initial assessment or evaluation, tips for determining the combination of assessment methods, and how to include third-party or product certification
     

The medical device industry is struggling, with a forecast of single-digit overall growth for 2014.

To cope with that, devicemakers are outsourcing more and more of their critical operations and materials, trying to wring out costs and improve their profitability. 

The unintended consequence?

A much, much greater risk of supplier control violations. After all, the more suppliers a company has, the more opportunities they give the FDA to find fault with their operations.

Some devicemakers say they have as many as 400 outsourced contract manufacturers and suppliers.

It's no surprise, then, that it has become increasingly difficult to manage them and be sure that all raw materials, finished products and services meet the devicemaker's required specifications as well as comply with FDA regulations.

This FDAnews virtual conference is designed especially to take the headaches out of working with an ever increasing number of suppliers. Sign up to attend and take home practical tools and invaluable tips that will help devicemakers be more confident that their outsourced work will not result in a Form 483 or warning letter.

There's simply so much that can go wrong when outsourcing. On Wednesday, Feb. 26, a panel of experts will spend the day, identifying and discussing such key problem areas as:

  • What non-compliance issues most frequently trigger an audit
     
  • Understanding global supplier monitoring requirements: Can an FDA-centric program fulfill international requirements?
     
  • Best practices for prioritizing a supplier control approach that will work for large or small companies
  • Managing supplier controls over the long haul to create good business relationships and assure FDA compliance
  • What motivates a supplier to do business
  • How to test SOPs against the most commonly cited sections of 21 CFR 820.50
     
  • Verifying that supplier dossiers contain the records FDA inspectors want to see
     
  • How to identify the warning letters that include hidden FDA requirements that tripped other companies up
     
  • Critical documents to have at the ready to print out and produce the moment the FDA inspector demands them

Register Today

Device Supplier Controls is a must-attend event for colleagues from the manufacturing floor to materials management, and the legal counsel's office to the executive suite.

  • Quality assurance/quality control
  • Operations
  • Manufacturing
  • Materials management
  • Purchasing
  • Packaging and labeling
  • Plant engineering
  • In-bound testing and certification
  • Regulatory affairs
  • Legal counsel

Keynote Speaker

Maria Isabel Tejero del Rio, MD, PhD, Lead Consumer Safety Officer, Division of Manufacturing and Quality, Office of Compliance, CDRH, FDA

Dr. Tejero was born in Spain where she trained as a physician. After practicing as a family physician in her home country, she moved to the United States and earned a PhD in Integrative Physiology. Conducting cardiovascular research in the US, she reached the position of Research Assistant Professor at George Washington University. In 2009, she joined the Office of Compliance at CDRH, where she works as a Consumer Safety Officer enforcing medical device regulations. For the past two years, she has specialized in the evaluation of premarket drug applications classified as combination products with a device constituent.

Meet the Faculty

John Avellanet, Principal Consultant, Cerulean Associates

David Parkin, Supplier Development Manager, Boston Scientific

Jackie Torfin, Vice President of Quality, Heraeus Medical Components

Mike Heyl, Partner, Hogan Lovell (invited)

Conference Details
Device Supplier Controls

Does the FDA's Next 483 Have Your Name on It?
**FDAnews Virtual Conference**
Feb. 26, 201410:00 a.m.4:00 p.m. EST
www.fdanews.com/DeviceSupplierQualityNewSpeakerdelRio

Tuition
$1,297 per site -- includes virtual conference registration and audio cds and transcripts

Easy Ways to Register
Online:       www.fdanews.com/DeviceSupplierQualityNewSpeakerdelRio
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
Cloud promises the agility required by today’s digital businesses. As organizations adopt cloud based infrastructures and services, their IT resources become increasingly dynamic and hybrid in nature. Managing these require modern IT operations and tools. In his session at 20th Cloud Expo, Raj Sundaram, Senior Principal Product Manager at CA Technologies, will discuss how to modernize your IT operations in order to proactively manage your hybrid cloud and IT environments. He will be sharing bes...
Regardless of what business you’re in, it’s increasingly a software-driven business. Consumers’ rising expectations for connected digital and physical experiences are driving what some are calling the "Customer Experience Challenge.” In his session at @DevOpsSummit at 20th Cloud Expo, Marco Morales, Director of Global Solutions at CollabNet, will discuss how organizations are increasingly adopting a discipline of Value Stream Mapping to ensure that the software they are producing is poised to o...
SYS-CON Events announced today that delaPlex will exhibit at SYS-CON's @CloudExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. delaPlex pioneered Software Development as a Service (SDaaS), which provides scalable resources to build, test, and deploy software. It’s a fast and more reliable way to develop a new product or expand your in-house team.
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm. In his Day 3 Keynote at 20th Cloud Expo, Chris Brown, a Solutions Marketing Manager at Nutanix, will explore t...
Five years ago development was seen as a dead-end career, now it’s anything but – with an explosion in mobile and IoT initiatives increasing the demand for skilled engineers. But apart from having a ready supply of great coders, what constitutes true ‘DevOps Royalty’? It’ll be the ability to craft resilient architectures, supportability, security everywhere across the software lifecycle. In his keynote at @DevOpsSummit at 20th Cloud Expo, Jeffrey Scheaffer, GM and SVP, Continuous Delivery Busine...
SYS-CON Events announced today that Outscale, a global pure play Infrastructure as a Service provider and strategic partner of Dassault Systèmes, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Founded in 2010, Outscale simplifies infrastructure complexities and boosts the business agility of its customers. Outscale delivers a secure, reliable and industrial strength solution for its customers, which in...
Most DevOps journeys involve several phases of maturity. Research shows that the inflection point where organizations begin to see maximum value is when they implement tight integration deploying their code to their infrastructure. Success at this level is the last barrier to at-will deployment. Storage, for instance, is more capable than where we read and write data. In his session at @DevOpsSummit at 20th Cloud Expo, Josh Atwell, a Developer Advocate for NetApp, will discuss the role and value...
SYS-CON Events announced today that CollabNet, a global leader in enterprise software development, release automation and DevOps solutions, will be a Bronze Sponsor of SYS-CON's 20th International Cloud Expo®, taking place from June 6-8, 2017, at the Javits Center in New York City, NY. CollabNet offers a broad range of solutions with the mission of helping modern organizations deliver quality software at speed. The company’s latest innovation, the DevOps Lifecycle Manager (DLM), supports Value S...
IBM helps FinTechs and financial services companies build and monetize cognitive-enabled financial services apps quickly and at scale. Hosted on IBM Bluemix, IBM’s platform builds in customer insights, regulatory compliance analytics and security to help reduce development time and testing. In his session at 20th Cloud Expo, Tom Eck, Industry Platforms CTO at IBM Cloud, will discuss how these tools simplify the time-consuming tasks of selection, mapping and data integration, allowing developers ...
In order to meet the rapidly changing demands of today’s customers, companies are continually forced to redefine their business strategies in order to meet these needs, stay relevant and continue to see profitable growth. IoT deployment and development is integral in this transformation, and today businesses are increasingly seeing the value of investing their resources into IoT deployments. These technologies are able increase ROI through projects such as connecting supply chains or enabling sm...
A strange thing is happening along the way to the Internet of Things, namely far too many devices to work with and manage. It has become clear that we'll need much higher efficiency user experiences that can allow us to more easily and scalably work with the thousands of devices that will soon be in each of our lives. Enter the conversational interface revolution, combining bots we can literally talk with, gesture to, and even direct with our thoughts, with embedded artificial intelligence, whic...
SYS-CON Events announced today that Peak 10, Inc., a national IT infrastructure and cloud services provider, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Peak 10 provides reliable, tailored data center and network services, cloud and managed services. Its solutions are designed to scale and adapt to customers’ changing business needs, enabling them to lower costs, improve performance and focus intern...
Everywhere we turn in our industry we can find strong opinions about the direction, type and nature of cloud’s impact on computing and business. Another word that is used in every context in our industry is “hybrid.” In his session at 20th Cloud Expo, Alvaro Gonzalez, Director of Technical, Partner and Field Marketing at Peak 10, will use a combination of a few conceptual props and some research recently commissioned by Peak 10 to offer a real-world consideration of how the various categories of...
Cloud applications are seeing a deluge of requests to support the exploding advanced analytics market. “Open analytics” is the emerging strategy to deliver that data through an open data access layer, in the cloud, to be directly consumed by external analytics tools and popular programming languages. An increasing number of data engineers and data scientists use a variety of platforms and advanced analytics languages such as SAS, R, Python and Java, as well as frameworks such as Hadoop and Spark...
SYS-CON Events announced today that Super Micro Computer, Inc., a global leader in compute, storage and networking technologies, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Supermicro (NASDAQ: SMCI), the leading innovator in high-performance, high-efficiency server technology, is a premier provider of advanced server Building Block Solutions® for Data Center, Cloud Computing, Enterprise IT, Hadoop/...