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. |
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 |
3:45 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 |