Welcome!

News Feed Item

FDAnews Announces Device Supplier Controls Virtual Conference, Feb. 26

FALLS CHURCH, Va., Feb. 10, 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/DeviceSupplierVirtual

(Photo: http://photos.prnewswire.com/prnh/20140210/MN62032)

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 you have, the more opportunities you give the FDA to find fault with your 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

Attendee Resource Toolkit — Registered attendees will also receive the following resources to help them better manage their supplier control program:

  • Slide decks from all five presentations
  • FDA's 21 CFR 820.50 regulation
  • A compilation of recent FDAnews articles related to supplier control problems at medical device manufacturers
  • New Therapeutic Goods Administration (TGA, Australia) guidance on supplier qualification for raw materials, drugmakers
  • GHTF/SG3/N17:2008  Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained From Suppliers

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)

William MacFarland, Director, Division of Enforcement, Office of Compliance, CDRH, FDA(invited)

Register now

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/DeviceSupplierVirtual

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

Easy Ways to Register

Online: www.fdanews.com/DeviceSupplierVirtual
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

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
In his session at @ThingsExpo, Eric Lachapelle, CEO of the Professional Evaluation and Certification Board (PECB), provided an overview of various initiatives to certify the security of connected devices and future trends in ensuring public trust of IoT. Eric Lachapelle is the Chief Executive Officer of the Professional Evaluation and Certification Board (PECB), an international certification body. His role is to help companies and individuals to achieve professional, accredited and worldwide re...
Amazon started as an online bookseller 20 years ago. Since then, it has evolved into a technology juggernaut that has disrupted multiple markets and industries and touches many aspects of our lives. It is a relentless technology and business model innovator driving disruption throughout numerous ecosystems. Amazon’s AWS revenues alone are approaching $16B a year making it one of the largest IT companies in the world. With dominant offerings in Cloud, IoT, eCommerce, Big Data, AI, Digital Assista...
When growing capacity and power in the data center, the architectural trade-offs between server scale-up vs. scale-out continue to be debated. Both approaches are valid: scale-out adds multiple, smaller servers running in a distributed computing model, while scale-up adds fewer, more powerful servers that are capable of running larger workloads. It’s worth noting that there are additional, unique advantages that scale-up architectures offer. One big advantage is large memory and compute capacity...
Both SaaS vendors and SaaS buyers are going “all-in” to hyperscale IaaS platforms such as AWS, which is disrupting the SaaS value proposition. Why should the enterprise SaaS consumer pay for the SaaS service if their data is resident in adjacent AWS S3 buckets? If both SaaS sellers and buyers are using the same cloud tools, automation and pay-per-transaction model offered by IaaS platforms, then why not host the “shrink-wrapped” software in the customers’ cloud? Further, serverless computing, cl...
You know you need the cloud, but you’re hesitant to simply dump everything at Amazon since you know that not all workloads are suitable for cloud. You know that you want the kind of ease of use and scalability that you get with public cloud, but your applications are architected in a way that makes the public cloud a non-starter. You’re looking at private cloud solutions based on hyperconverged infrastructure, but you’re concerned with the limits inherent in those technologies.
The taxi industry never saw Uber coming. Startups are a threat to incumbents like never before, and a major enabler for startups is that they are instantly “cloud ready.” If innovation moves at the pace of IT, then your company is in trouble. Why? Because your data center will not keep up with frenetic pace AWS, Microsoft and Google are rolling out new capabilities. In his session at 20th Cloud Expo, Don Browning, VP of Cloud Architecture at Turner, posited that disruption is inevitable for comp...
Internet of @ThingsExpo, taking place October 31 - November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 21st Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The Internet of Things (IoT) is the most profound change in personal and enterprise IT since the creation of the Worldwide Web more than 20 years ago. All major researchers estimate there will be tens of billions devic...
It is ironic, but perhaps not unexpected, that many organizations who want the benefits of using an Agile approach to deliver software use a waterfall approach to adopting Agile practices: they form plans, they set milestones, and they measure progress by how many teams they have engaged. Old habits die hard, but like most waterfall software projects, most waterfall-style Agile adoption efforts fail to produce the results desired. The problem is that to get the results they want, they have to ch...
IoT solutions exploit operational data generated by Internet-connected smart “things” for the purpose of gaining operational insight and producing “better outcomes” (for example, create new business models, eliminate unscheduled maintenance, etc.). The explosive proliferation of IoT solutions will result in an exponential growth in the volume of IoT data, precipitating significant Information Governance issues: who owns the IoT data, what are the rights/duties of IoT solutions adopters towards t...
Wooed by the promise of faster innovation, lower TCO, and greater agility, businesses of every shape and size have embraced the cloud at every layer of the IT stack – from apps to file sharing to infrastructure. The typical organization currently uses more than a dozen sanctioned cloud apps and will shift more than half of all workloads to the cloud by 2018. Such cloud investments have delivered measurable benefits. But they’ve also resulted in some unintended side-effects: complexity and risk. ...
With the introduction of IoT and Smart Living in every aspect of our lives, one question has become relevant: What are the security implications? To answer this, first we have to look and explore the security models of the technologies that IoT is founded upon. In his session at @ThingsExpo, Nevi Kaja, a Research Engineer at Ford Motor Company, discussed some of the security challenges of the IoT infrastructure and related how these aspects impact Smart Living. The material was delivered interac...
"When we talk about cloud without compromise what we're talking about is that when people think about 'I need the flexibility of the cloud' - it's the ability to create applications and run them in a cloud environment that's far more flexible,” explained Matthew Finnie, CTO of Interoute, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
No hype cycles or predictions of zillions of things here. IoT is big. You get it. You know your business and have great ideas for a business transformation strategy. What comes next? Time to make it happen. In his session at @ThingsExpo, Jay Mason, Associate Partner at M&S Consulting, presented a step-by-step plan to develop your technology implementation strategy. He discussed the evaluation of communication standards and IoT messaging protocols, data analytics considerations, edge-to-cloud tec...
The Internet giants are fully embracing AI. All the services they offer to their customers are aimed at drawing a map of the world with the data they get. The AIs from these companies are used to build disruptive approaches that cannot be used by established enterprises, which are threatened by these disruptions. However, most leaders underestimate the effect this will have on their businesses. In his session at 21st Cloud Expo, Rene Buest, Director Market Research & Technology Evangelism at Ara...
A look across the tech landscape at the disruptive technologies that are increasing in prominence and speculate as to which will be most impactful for communications – namely, AI and Cloud Computing. In his session at 20th Cloud Expo, Curtis Peterson, VP of Operations at RingCentral, highlighted the current challenges of these transformative technologies and shared strategies for preparing your organization for these changes. This “view from the top” outlined the latest trends and developments i...