CAPA Documentation and Filing Agenda
CAPA Documentation and Filing
Tackling the Least Understood Parts of the Process
An FDAnews Virtual Conference
Thursday, Jan. 31, 2013 • 10:00 a.m. – 4:00 p.m. EST
10:00 a.m. – 10:15 a.m. |
Welcome Chairperson Deborah Lydick, President, Catalyst Advantage Group, LLC |
10:15 a.m. – 11:15 a.m. |
Data, Data Everywhere, But What’s Most Important for Effective CAPA Documentation? Attendees will learn:
Deborah Lydick, President, Catalyst Advantage Group, LLC |
11:15 a.m. – 11:30 a.m. |
Break |
11:30 a.m. – 12:30 p.m. |
Stuffing Files in a Shoebox Won’t Do — Tips and Tricks for Maintaining an Effective CAPA Filling System Attendees will learn:
Jim Shore, Product/Process Improvement Leader, Dynisco LLC |
12:30 p.m. – 1:30 p.m. |
Lunch |
1:30 p.m. – 2:30 p.m. |
Writing Effective CAPA Reports – Do You Really Know What They Should Contain? Attendees will learn:
Joe Goodman, Director of Solutions Consulting, Sparta Systems |
2:30 p.m. – 2:45 p.m. |
Break |
2:45 p.m. – 3:45 p.m. |
Good vs. Bad CAPA Documentation Reports: A Walk-Through Case Study Attendees will learn:
John Freije, Principal Medical Device Consultant, Freije Quality Engineering, LLC |
3:45 p.m. – 4:00 p.m. |
Closing Remarks |