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
- CAPA procedures, 820.100 (a)
- Compliant procedures, 820.198 (a)
- Written MDR procedures, 803.17
- CAPA documentation, 820.100 (b)
- Process validation, 820.75 (a)
- Device master record, 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)
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
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.
