|By PR Newswire||
|February 21, 2014 10:14 AM EST||
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, 2014 — 10:00 a.m. – 4:00 p.m. EST
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
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
- Materials management
- Packaging and labeling
- Plant engineering
- In-bound testing and certification
- Regulatory affairs
- Legal counsel
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)
Device Supplier Controls
Does the FDA's Next 483 Have Your Name on It?
**FDAnews Virtual Conference**
Feb. 26, 2014 — 10:00 a.m. – 4:00 p.m. EST
$1,297 per site -- includes virtual conference registration and audio cds and transcripts
Easy Ways to Register
By phone: 888-838-5578 or 703-538-7600
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
Building a cross-cloud operational model can be a daunting task. Per-cloud silos are not the answer, but neither is a fully generic abstraction plane that strips out capabilities unique to a particular provider. In his session at 20th Cloud Expo, Chris Wolf, VP & Chief Technology Officer, Global Field & Industry at VMware, will discuss how successful organizations approach cloud operations and management, with insights into where operations should be centralized and when it’s best to decentraliz...
Apr. 25, 2017 06:45 AM EDT Reads: 184
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...
Apr. 25, 2017 06:45 AM EDT
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.
Apr. 25, 2017 06:30 AM EDT
SYS-CON Events announced today that Hitachi, the leading provider the Internet of Things and Digital Transformation, 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. Hitachi Data Systems, a wholly owned subsidiary of Hitachi, Ltd., offers an integrated portfolio of services and solutions that enable digital transformation through enhanced data management, governance, mobility and analytics. We help globa...
Apr. 25, 2017 06:15 AM EDT Reads: 765
In his session at 20th Cloud Expo, Scott Davis, CTO of Embotics, will discuss how automation can provide the dynamic management required to cost-effectively deliver microservices and container solutions at scale. He will discuss how flexible automation is the key to effectively bridging and seamlessly coordinating both IT and developer needs for component orchestration across disparate clouds – an increasingly important requirement at today’s multi-cloud enterprise.
Apr. 25, 2017 06:00 AM EDT Reads: 4,263
Developers want to create better apps faster. Static clouds are giving way to scalable systems, with dynamic resource allocation and application monitoring. You won't hear that chant from users on any picket line, but helping developers to create better apps faster is the mission of Lee Atchison, principal cloud architect and advocate at New Relic Inc., based in San Francisco. His singular job is to understand and drive the industry in the areas of cloud architecture, microservices, scalability ...
Apr. 25, 2017 05:00 AM EDT Reads: 3,346
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...
Apr. 25, 2017 05:00 AM EDT Reads: 160
The 20th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held June 6-8, 2017, at the Javits Center in New York City, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Containers, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportunity. Submit your speaking proposal ...
Apr. 25, 2017 05:00 AM EDT Reads: 806
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/...
Apr. 25, 2017 04:30 AM EDT Reads: 1,985
Join IBM November 2 at 19th Cloud Expo at the Santa Clara Convention Center in Santa Clara, CA, and learn how to go beyond multi-speed it to bring agility to traditional enterprise applications. Technology innovation is the driving force behind modern business and enterprises must respond by increasing the speed and efficiency of software delivery. The challenge is that existing enterprise applications are expensive to develop and difficult to modernize. This often results in what Gartner calls ...
Apr. 25, 2017 04:30 AM EDT Reads: 2,992
All organizations that did not originate this moment have a pre-existing culture as well as legacy technology and processes that can be more or less amenable to DevOps implementation. That organizational culture is influenced by the personalities and management styles of Executive Management, the wider culture in which the organization is situated, and the personalities of key team members at all levels of the organization. This culture and entrenched interests usually throw a wrench in the work...
Apr. 25, 2017 04:15 AM EDT Reads: 166
Amazon has gradually rolled out parts of its IoT offerings in the last year, but these are just the tip of the iceberg. In addition to optimizing their back-end AWS offerings, Amazon is laying the ground work to be a major force in IoT – especially in the connected home and office. Amazon is extending its reach by building on its dominant Cloud IoT platform, its Dash Button strategy, recently announced Replenishment Services, the Echo/Alexa voice recognition control platform, the 6-7 strategic...
Apr. 25, 2017 04:15 AM EDT Reads: 4,992
With billions of sensors deployed worldwide, the amount of machine-generated data will soon exceed what our networks can handle. But consumers and businesses will expect seamless experiences and real-time responsiveness. What does this mean for IoT devices and the infrastructure that supports them? More of the data will need to be handled at - or closer to - the devices themselves.
Apr. 25, 2017 03:45 AM EDT Reads: 193
New competitors, disruptive technologies, and growing expectations are pushing every business to both adopt and deliver new digital services. This ‘Digital Transformation’ demands rapid delivery and continuous iteration of new competitive services via multiple channels, which in turn demands new service delivery techniques – including DevOps. In this power panel at @DevOpsSummit 20th Cloud Expo, moderated by DevOps Conference Co-Chair Andi Mann, panelists will examine how DevOps helps to meet th...
Apr. 25, 2017 03:45 AM EDT Reads: 950
@GonzalezCarmen has been ranked the Number One Influencer and @ThingsExpo has been named the Number One Brand in the “M2M 2016: Top 100 Influencers and Brands” by Analytic. Onalytica analyzed tweets over the last 6 months mentioning the keywords M2M OR “Machine to Machine.” They then identified the top 100 most influential brands and individuals leading the discussion on Twitter.
Apr. 25, 2017 03:45 AM EDT Reads: 801