|By PR Newswire||
|February 10, 2014 05:33 PM EST||
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, 2014 — 10:00 a.m. – 4:00 p.m. EST
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
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
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)
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
Internet-of-Things discussions can end up either going down the consumer gadget rabbit hole or focused on the sort of data logging that industrial manufacturers have been doing forever. However, in fact, companies today are already using IoT data both to optimize their operational technology and to improve the experience of customer interactions in novel ways. In his session at @ThingsExpo, Gordon Haff, Red Hat Technology Evangelist, will share examples from a wide range of industries – includin...
Dec. 8, 2016 07:00 AM EST Reads: 1,691
"We build IoT infrastructure products - when you have to integrate different devices, different systems and cloud you have to build an application to do that but we eliminate the need to build an application. Our products can integrate any device, any system, any cloud regardless of protocol," explained Peter Jung, Chief Product Officer at Pulzze Systems, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 8, 2016 06:30 AM EST Reads: 1,114
Keeping pace with advancements in software delivery processes and tooling is taxing even for the most proficient organizations. Point tools, platforms, open source and the increasing adoption of private and public cloud services requires strong engineering rigor – all in the face of developer demands to use the tools of choice. As Agile has settled in as a mainstream practice, now DevOps has emerged as the next wave to improve software delivery speed and output. To make DevOps work, organization...
Dec. 8, 2016 06:15 AM EST Reads: 5,910
Get deep visibility into the performance of your databases and expert advice for performance optimization and tuning. You can't get application performance without database performance. Give everyone on the team a comprehensive view of how every aspect of the system affects performance across SQL database operations, host server and OS, virtualization resources and storage I/O. Quickly find bottlenecks and troubleshoot complex problems.
Dec. 8, 2016 05:00 AM EST Reads: 2,159
Internet of @ThingsExpo has announced today that Chris Matthieu has been named tech chair of Internet of @ThingsExpo 2017 New York The 7th Internet of @ThingsExpo will take place on June 6-8, 2017, at the Javits Center in New York City, New York. Chris Matthieu is the co-founder and CTO of Octoblu, a revolutionary real-time IoT platform recently acquired by Citrix. Octoblu connects things, systems, people and clouds to a global mesh network allowing users to automate and control design flo...
Dec. 8, 2016 04:30 AM EST Reads: 733
"We are an all-flash array storage provider but our focus has been on VM-aware storage specifically for virtualized applications," stated Dhiraj Sehgal of Tintri in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 8, 2016 04:15 AM EST Reads: 947
With 15% of enterprises adopting a hybrid IT strategy, you need to set a plan to integrate hybrid cloud throughout your infrastructure. In his session at 18th Cloud Expo, Steven Dreher, Director of Solutions Architecture at Green House Data, discussed how to plan for shifting resource requirements, overcome challenges, and implement hybrid IT alongside your existing data center assets. Highlights included anticipating workload, cost and resource calculations, integrating services on both sides...
Dec. 8, 2016 04:00 AM EST Reads: 3,799
"We're a cybersecurity firm that specializes in engineering security solutions both at the software and hardware level. Security cannot be an after-the-fact afterthought, which is what it's become," stated Richard Blech, Chief Executive Officer at Secure Channels, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 8, 2016 04:00 AM EST Reads: 1,046
Unless your company can spend a lot of money on new technology, re-engineering your environment and hiring a comprehensive cybersecurity team, you will most likely move to the cloud or seek external service partnerships. In his session at 18th Cloud Expo, Darren Guccione, CEO of Keeper Security, revealed what you need to know when it comes to encryption in the cloud.
Dec. 8, 2016 04:00 AM EST Reads: 4,815
According to Forrester Research, every business will become either a digital predator or digital prey by 2020. To avoid demise, organizations must rapidly create new sources of value in their end-to-end customer experiences. True digital predators also must break down information and process silos and extend digital transformation initiatives to empower employees with the digital resources needed to win, serve, and retain customers.
Dec. 8, 2016 02:45 AM EST Reads: 1,301
"We are the public cloud providers. We are currently providing 50% of the resources they need for doing e-commerce business in China and we are hosting about 60% of mobile gaming in China," explained Yi Zheng, CPO and VP of Engineering at CDS Global Cloud, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 8, 2016 02:30 AM EST Reads: 1,121
The WebRTC Summit New York, to be held June 6-8, 2017, at the Javits Center in New York City, NY, announces that its Call for Papers is now open. Topics include all aspects of improving IT delivery by eliminating waste through automated business models leveraging cloud technologies. WebRTC Summit is co-located with 20th International Cloud Expo and @ThingsExpo. WebRTC is the future of browser-to-browser communications, and continues to make inroads into the traditional, difficult, plug-in web co...
Dec. 8, 2016 01:45 AM EST Reads: 1,410
Between 2005 and 2020, data volumes will grow by a factor of 300 – enough data to stack CDs from the earth to the moon 162 times. This has come to be known as the ‘big data’ phenomenon. Unfortunately, traditional approaches to handling, storing and analyzing data aren’t adequate at this scale: they’re too costly, slow and physically cumbersome to keep up. Fortunately, in response a new breed of technology has emerged that is cheaper, faster and more scalable. Yet, in meeting these new needs they...
Dec. 8, 2016 01:30 AM EST Reads: 1,926
When it comes to cloud computing, the ability to turn massive amounts of compute cores on and off on demand sounds attractive to IT staff, who need to manage peaks and valleys in user activity. With cloud bursting, the majority of the data can stay on premises while tapping into compute from public cloud providers, reducing risk and minimizing need to move large files. In his session at 18th Cloud Expo, Scott Jeschonek, Director of Product Management at Avere Systems, discussed the IT and busin...
Dec. 8, 2016 01:00 AM EST Reads: 3,957
In his general session at 19th Cloud Expo, Manish Dixit, VP of Product and Engineering at Dice, discussed how Dice leverages data insights and tools to help both tech professionals and recruiters better understand how skills relate to each other and which skills are in high demand using interactive visualizations and salary indicator tools to maximize earning potential. Manish Dixit is VP of Product and Engineering at Dice. As the leader of the Product, Engineering and Data Sciences team at D...
Dec. 8, 2016 12:30 AM EST Reads: 1,138