FDAnews Announces CAPA Documentation and Filing: Virtual Conference

PR Newswire
Friday, January 25th 2013

FALLS CHURCH, Va., Jan. 25, 2013 /PRNewswire-iReach/ --

CAPA Documentation and Filing
Tackling the Least Understood Parts of the Process

**Virtual Conference**
Jan. 31, 2013, 10:00 a.m.4:00 p.m. EST



You could have the world's greatest surveillance network to alert you to CAPA problems, your failure investigation teams could be top-notch, but if you fail to write clear and concise reports, include the right level of documentation and file these CAPAs so they're easily handed to the FDA during an inspection, you've failed.

On Thursday, Jan. 31, 2013, from 10 a.m. to 4 p.m. EST, FDAnews is presenting four back-to-back sessions dedicated to CAPA documentation and filing.  No other event in the industry has tackled this complex subject like this.  Register Today.

A top-notch investigation is no good if your report is not clear and concise enough to pass FDA scrutiny. Would your CAPA documentation pass FDA scrutiny?

You're going to master CAPA documentation and filing compliance in just one day.  Here's how.

You'll hear from four experts on FDA documentation regulations, filing systems, report preparation, and best practices for correcting mistakes.  You'll come away from this virtual conference knowing how to transform your CAPA documentation and filing problems into successes.

Get answers to your toughest documentation questions — in just a day.  No travel required. 


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.

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.

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.

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