Welcome!

News Feed Item

FDAnews Announces Device Manufacturing Compliance Crash Course Virtual Conference

FALLS CHURCH, Va., Dec. 12, 2012 /PRNewswire-iReach/ -- Device Manufacturing Compliance Crash Course
Solutions to the Top 10 QSR Violations
**Virtual Conference**
Dec. 19, 2012, 10:00 a.m.4:00 p.m. EST

(Photo: http://photos.prnewswire.com/prnh/20121212/CG28884)

www.fdanews.com/DeviceCrashCourse

FDA inspectors are focusing their attention on very specific violations within device and diagnostics companies.  And it's showing up in 483s and warning letters. 

Here's a Top 10 list you don't want to be on:

Top 10 FDA Form 483 Citations for Medical Device Firms for Last Year

  1. CAPA procedures, 820.100 (a)
  2. Compliant procedures, 820.198 (a)
  3. Written MDR procedures, 803.17
  4. CAPA documentation, 820.100 (b)
  5. Process validation, 820.75 (a)
  6. Device master record, 820.181
  7. Purchasing controls, 820.50
  8. Control of non-conforming product, 820.90 (a)
  9. Quality audit procedures, 820.22
  10. Design change procedures, 820.30 (i)

Tackle these 10 problems and assure smooth sailing through your next inspection.

Join FDAnews Wednesday, Dec. 19, 2012, from 10 a.m. to 4 p.m. EST as we host a virtual conference that will give you concrete knowledge and solutions to the top 10 mistakes device manufacturers are currently making.

If you have questions, we have answers. Register Today

Master device manufacturing compliance in just one day.  Here's how.

Featuring six speakers focusing on the trends, FDA regulations and best practices for avoiding mistakes, attendees will come away with ideas on how to transform their device manufacturing compliance problems.

Get answers to your toughest questions — in just a day.  No travel required.  Gather your colleagues for the best, and most cost effective, training in the industry.

Your virtual conference chairperson is James Wason, Ph.D, principal of Maelor Group Lifesciences Consulting. Dr. Wason has more than 35 years of experience working with device manufacturers.

Agenda:
10:00 a.m.10:15 a.m.
Introduction to the Virtual Conference
Chairperson Dr. James Wason, Principal, Maelor Group Lifesciences Consulting

10:15 a.m.11:00 a.m.
Solving the Industry's #1 Problem — Best Practices for Dealing with CAPA Procedures, Section 820.100 (a)
Dr. James Wason, Principal, Maelor Group Lifesciences Consulting

11:00 a.m.11:45 a.m.
There's No Complaining About Industry's #2 Problem — Closing the Loop on QSR's Compliant Procedures, Section 820.198 (a)
Karl Vahey, Senior Director RA Compliance, International RA/QA, Covidien

11:45 a.m.12:00 p.m.
Break

12:00 p.m.12:45 p.m.
So You Have a Complaint Program, But Does Anyone Really Know What to Do?  Understanding the FDA's Written MDR Procedures Section 803.17
Judith Andrews, Director of Quality and Compliance Services, Aptiv Solutions

12:45 p.m.1:30 p.m.
If it's Not Written Down, It Didn't Happen — What Should Really Be in a CAPA File — Understanding the Scope of CAPA Documentation, Section 820.100 (b)
Deb Lydick, President, Catalyst Advantage Group, LLC

1:30 p.m.2:30 p.m.
Lunch

2:30 p.m.3:15 p.m.
The Fourth Most Troubling Problem — And It's on the Rise — Building Compliant Process Validation Programs, Section 820.75 (a) 
Dr. Vinny Sastri, President, WINOVIA® LLC

3:15 p.m.4:00 p.m.
Rapid Fire Solutions Session — Tips and Tricks for Complying with Top 483 Violations — Device Master Records, 820.181, Purchasing Controls, 820.50, Control of Non-conforming Product, 820.90 (a), Quality Audit Procedures, 820.22, Design Change Procedures, 820.30 (i)
Jim Shore, Product/Process Improvement Leader, Dynisco LLC

Register Today

The virtual conference is convenient to attend. All that's required is that you be in front of a computer monitor at the appointed time, whether you're at the office or telecommuting from your office-in-home.

Of course, the panel of experts will be on hand to answer all of your questions. Simply submit your questions via email, and you'll have answers by the time the session ends.

Everyone in your organization with a role in product development, legal and regulatory affairs will benefit from taking part in this event — and they can do so at a cost that won't break the budget. You pay a single low registration fee per facility, regardless of how many participate. So spread the word.

Sign up for Medical Device Compliance Crash Course today.

Who Will Benefit

  • Auditors
  • Compliance officers
  • Consultants/service providers
  • Engineering and design control teams
  • Executive management
  • General/corporate counsel
  • Investigators
  • Managers
  • Manufacturing directors and supervisors
  • Personnel new to the industry
  • Pharmaceutical and cGMP auditors
  • QA/QC personnel
  • R&D staff
  • Regulatory affairs professionals
  • Risk management specialists
  • Training personnel

Meet Your Instructors
Judith Andrews, Director of Quality and Compliance Services, Aptiv Solutions
Deb Lydick, President, Catalyst Advantage Group LLC
Vinny Sastri, Ph.D, President, WINOVIA® LLC
Jim Shore, Product and Process Improvement Leader, Dynisco LLC
Karl Vahey, Senior Director RA Compliance, International RA/QA, Covidien
James Wason, Ph.D, Principal, Maelor Group Lifesciences Consulting (Chair)

Here's How It Works
Twenty-four hours prior to the Virtual Conference on Wednesday, attendees will receive all presentations.

Then, just log on to the Virtual Conference website and dial a toll-free number, both provided in your registration confirmation. And relax. That's all there is to it.

Key people throughout your company will benefit from taking part in this event. Best of all, everyone can do so at a cost that won't break the budget. You pay one low registration fee per facility, regardless of how many participate. So spread the word.

Don't take unnecessary risks. Sign up today for this timely learning event.

  • Stress-free! No airport security hassles, no 4 a.m. wakeups, no anonymous  hotel rooms. You never even leave your building — not even your own desk.
  • Interactive! Constant opportunities to ask questions and get involved. Send in queries via e-mail ... you'll have answers before you log off.
  • Up-to-the-minute! Every speaker operates in the real world, in real time. If news breaks on Virtual Conference morning, you'll hear about it before the             session ends.
  • Great value! Spread the word! There's no limit on number of attendees per site. One low registration fee covers them all. Or register three or more locations for deeper discounts still.

Conference Details
Device Manufacturing Compliance Crash Course
Solutions to the Top 10 QSR Violations
**Virtual Conference**
Dec. 19, 2012, 10:00 a.m.4:00 p.m. EST

Tuition: $1,297 per site — includes virtual conference rebroadcast registration and audio cds and transcripts

4 Easy Ways to Register

Online:        www.fdanews.com/DeviceCrashCourse

By phone:   888-838-5578 or 703-538-7600

Fax:            703-538-7676

Mail to:       FDAnews
                   300 N Washington St
                   Ste 200
                   Fall Church VA USA 22046-3431

Media Contact: Jeff Grizzel FDAnews, 703-538-7668, [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
What sort of WebRTC based applications can we expect to see over the next year and beyond? One way to predict development trends is to see what sorts of applications startups are building. In his session at @ThingsExpo, Arin Sime, founder of WebRTC.ventures, will discuss the current and likely future trends in WebRTC application development based on real requests for custom applications from real customers, as well as other public sources of information,
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
SYS-CON Events announced today that Ocean9will 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. Ocean9 provides cloud services for Backup, Disaster Recovery (DRaaS) and instant Innovation, and redefines enterprise infrastructure with its cloud native subscription offerings for mission critical SAP workloads.
Interoute has announced the integration of its Global Cloud Infrastructure platform with Rancher Labs’ container management platform, Rancher. This approach enables enterprises to accelerate their digital transformation and infrastructure investments. Matthew Finnie, Interoute CTO commented “Enterprises developing and building apps in the cloud and those on a path to Digital Transformation need Digital ICT Infrastructure that allows them to build, test and deploy faster than ever before. The int...
Have you ever noticed how some IT people seem to lead successful, rewarding, and satisfying lives and careers, while others struggle? IT author and speaker Don Crawley uncovered the five principles that successful IT people use to build satisfying lives and careers and he shares them in this fast-paced, thought-provoking webinar. You'll learn the importance of striking a balance with technical skills and people skills, challenge your pre-existing ideas about IT customer service, and gain new in...
SYS-CON Events announced today that Juniper Networks (NYSE: JNPR), an industry leader in automated, scalable and secure networks, 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. Juniper Networks challenges the status quo with products, solutions and services that transform the economics of networking. The company co-innovates with customers and partners to deliver automated, scalable and secure network...
In his session at @ThingsExpo, Eric Lachapelle, CEO of the Professional Evaluation and Certification Board (PECB), will provide an overview of various initiatives to certifiy 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 worldw...
VeriStor Systems has announced that CRN has named VeriStor to its 2017 Managed Service Provider (MSP) 500 list in the Elite 150 category. This annual list recognizes North American solution providers with cutting-edge approaches to delivering managed services. Their offerings help companies navigate the complex and ever-changing landscape of IT, improve operational efficiencies, and maximize their return on IT investments. In today’s fast-paced business environments, MSPs play an important role...
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...
What if you could build a web application that could support true web-scale traffic without having to ever provision or manage a single server? Sounds magical, and it is! In his session at 20th Cloud Expo, Chris Munns, Senior Developer Advocate for Serverless Applications at Amazon Web Services, will show how to build a serverless website that scales automatically using services like AWS Lambda, Amazon API Gateway, and Amazon S3. We will review several frameworks that can help you build serverle...
SYS-CON Events announced today that Linux Academy, the foremost online Linux and cloud training platform and community, 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. Linux Academy was founded on the belief that providing high-quality, in-depth training should be available at an affordable price. Industry leaders in quality training, provided services, and student certification passes, its goal is to c...
SYS-CON Events announced today that Interoute, owner-operator of one of Europe's largest networks and a global cloud services platform, has been named “Bronze Sponsor” of SYS-CON's 20th Cloud Expo, which will take place on June 6-8, 2017 at the Javits Center in New York, New York. Interoute is the owner-operator of one of Europe's largest networks and a global cloud services platform which encompasses 12 data centers, 14 virtual data centers and 31 colocation centers, with connections to 195 add...
SYS-CON Events announced today that Telecom Reseller has been named “Media Sponsor” of 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. Telecom Reseller reports on Unified Communications, UCaaS, BPaaS for enterprise and SMBs. They report extensively on both customer premises based solutions such as IP-PBX as well as cloud based and hosted platforms.
FinTech is the sum of financial and technology, and it’s one of the fastest growing tech industries. Total global investments in FinTech almost reached $50 billion last year, but there is still a great deal of confusion over what it is and what it means – especially as it applies to retirement. Building financial startups is not simple, but with the right team, technology and an innovative approach it can be an extremely interesting domain to disrupt. FinTech heralds a financial revolution that...
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...