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?
820.100(b) states that all activities under CAPA and their results shall be documented.  If you’re conducting in-depth root cause analysis and failure investigations, you’re going to unearth a mountain of data and information.  In the end, you’ll have supplier data, acceptance reports, production records, interviews with employees and third-party contractors.  But what’s the most important of these sources of data and, more importantly, what does the FDA want to see in your final CAPA reports and supporting documentation?  This presentation will teach you the what, why and how of planning, establishing data sources, measurement and analysis, and improvement of your CAPA documentation.

Attendees will learn:

  • Why documentation is so important to the FDA and what specifically do they require
  • How the FDA’s requirements should drive your document sourcing and what’s too little and too much to include in your CAPA reports

Deborah Lydick, President, Catalyst Advantage Group, LLC

11:15 a.m. – 11:30 a.m.


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
When customer complaints, deviations, adverse events and other incidents that can trigger a CAPA are collected manually, there's no guarantee that all critical information will be captured because they are easy to misplace and it’s time-consuming to update paper reports.  FDA 483s and warning letters have exposed firms that kept these important CAPA-related documents in shoeboxes, dusty 3-ring binders, old metal file cabinets or worse.  Some firms just don’t keep CAPA-related documentation at all.  This session will teach attendees proven time-saving CAPA filing techniques.  Plus, ways to assure that your CAPA filing system is effective when the FDA requests documents during an inspection.

Attendees will learn:

  • How best-in-class firms develop and maintain effective CAPA documentation storage filing, and  labeling
  • How to teach staff to understand and respect documentation rules —  i.e., how forward and backward traceability guarantees effective file management and retrieval
  • If files can’t be found during an inspection, how to ask for and defend a documentation request extension

Jim Shore, Product/Process Improvement Leader, Dynisco LLC

12:30 p.m. – 1:30 p.m.


1:30 p.m. – 2:30 p.m.

Writing Effective CAPA Reports – Do You Really Know What They Should Contain?
Successful CAPA reports require significant planning and prioritization. This session will describe to you in detail how to correctly craft a report to FDA standards so that it maintains its purpose to allow others to make a decision.

Attendees will learn:

  • How to use critical thinking when outlining reports — what makes an insightful observation rather than stating the obvious
  • Examples of how successful reports are structured and what they contain
  • Tips on crafting the all-important executive summary
  • How to design a report to be easily skimmed by senior management and other departments, but most importantly one that can be used to initiate change and    serve compliance goals

Joe Goodman, Director of Solutions Consulting, Sparta Systems
Nancy Singer, President, Compliance Alliance, LLC

2:30 p.m. – 2:45 p.m.


2:45 p.m. – 3:45 p.m.

Good vs. Bad CAPA Documentation Reports: A Walk-Through Case Study
This session will provide an analysis of correct and incorrect documentation reports. This interactive presentation will describe tools and approaches for monitoring a CAPA report’s effectiveness and what changes to make to bad reports.

Attendees will learn:

  • How to spot bad CAPA documentation and improve it quickly
  • Tips and techniques for extracting usable data or information from wary or non-responsive  suppliers or contractors

John Freije, Principal Medical Device Consultant, Freije Quality Engineering, LLC

3:45 p.m. – 4:00 p.m.

Closing Remarks