Device Manufacturing Compliance Crash Course Agenda

Device Manufacturing Compliance Crash Course:
Solutions to the Top 10 QSR Violations
An FDAnews Virtual Conference
Wednesday, Dec. 19, 2012 • 10:00 a.m. – 4:00 p.m. EST

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

3:45 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