FALLS CHURCH, Va., Jan. 29, 2013 /PRNewswire-iReach/ -- CAPA Documentation and Filing
Tackling the Least Understood Parts of the Process
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, 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
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.
3:45 p.m. – 4:00 p.m.
The virtual conference is convenient to attend. All that's required is that you be in front of a computer screen at the appointed time, whether you're at the office or telecommuting from your office-in-home.
Of course, the panel of experts will be on hand to answer all of your questions. Simply submit your questions via email, and you'll have answers by the time the session ends.
Everyone in your organization with a role in product development, legal and regulatory affairs will benefit from taking part in this event — and they can do so at a cost that won't break the budget. You pay a single low registration fee per facility, regardless of how many participate. So spread the word.
Who Will Benefit
- CAPA mangers
- QA/QC managers and directors
- Compliance officers
- Training managers
- GCP, GLP or GMP professionals
- Regulatory affairs managers
- Quality engineers Here's How It WorksTwenty-four hours prior to the Virtual Conference on Thursday, attendees will receive all presentations.
Key people throughout your company will benefit from taking part in this event. Best of all, everyone can do so at a cost that won't break the budget. You pay one single low registration fee per facility, regardless of how many participate. So spread the word.
Don't take unnecessary risks. Sign up today for this timely learning event.
- Stress-free! No airport security hassles, no 4 a.m. wakeups, no anonymous hotel rooms. You never even leave your building — not even your own desk.
- Interactive! Constant opportunities to ask questions and get involved. Send in queries via e-mail ... you'll have answers before you log off.
- Up-to-the-minute! Every speaker operates in the real world, in real time. If news breaks on Virtual Conference morning, you'll hear about it before the session ends.
- Great value! Spread the word! There's no limit on number of attendees per site. One low registration fee covers them all. Or register three or more locations for deeper discounts still. Conference DetailsCAPA Documentation and FilingTackling the Least Understood Parts of the Process**Virtual Conference**Jan. 31, 2013, 10:00 a.m. – 4:00 p.m. EST
Tuition: $1,297 per site — includes virtual conference rebroadcast registration and audio cds and transcripts
4 Easy Ways to Register
By phone: 888-838-5578 or 703-538-7600
Mail to: FDAnews
300 N Washington St
Falls Church VA USA 22046-3431
Jeff Grizzel FDAnews, 703-538-7668, firstname.lastname@example.org
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