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In many cases, the end of the year gives you time to step back and take stock of the last 12 months. This is when many of us take a hard look at what worked and what did not, complete performance reviews, and formulate plans for the coming year. For me, it is all of those things plus a time when I u...
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


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.

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.

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.

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


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,

News distributed by PR Newswire iReach:


About 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.

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