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Sneak Preview: Complaint Handling and the Risk-Based QMS - Seminar


seminar2012Next week (April 24, 2012 at 8:30am ET to be more specific) we will be hosting our 3rd Annual Life Science Seminar in lovely Waltham Woods in Waltham, MA (wicked lovely).  This will be our third year doing this great event, and with each year, we hope to provide a venue to learn and share about the various topics in the Life Science community.  This year we have speakers from EtQ, Kimberly-Clark Corporation, and Celgene Corporation.

This year, we're going into Complaint Handling and the holistic Quality Management System.  Whether you're a Fortune 100 giant, or a small start-up with a great idea, if you have products out in the market, you will receive "post-market feedback" - or complaints.  They come in all shapes and sizes, and all varying degrees of severity. If you are like most companies, you will get more than a few.  Some companies have to devise new ways to organize, filter and rank these complaints, or adverse events in the broader sense, and handle them in a way that helps to foster greater compliance.

There are a few things to consider when automating the Complaint Handling process:

1.  Integration with other business systems:  One of the key areas for any automated Quality Management Solution is integration.  In order to gain complete visibility into the entire post-market process, integrating your Complaint Handling with 3rd party systems can give you the best way to ensure that data is accurate and information is being communicated from all parts of the business.  The seminar next week will feature a case study on just that - integrating Complaints with Sales automation tools.

2.  Use Risk to Filter Complaints:  We've talked about Risk in many facets on this blog, and this is something that is not new to our readers.  One of the key areas where risk can be implemented in a Quality Management System is through the filtering of adverse events, namely complaints, by their risk.  Using Risk tools, you can effectively sort and filter events by their overall risk ranking (severity, frequency, etc), and prioritize the events that pose the greatest risk, versus those that are latest.  In the Seminar we will go over this very thing.

The other aspect to this seminar will be on the Holistic Quality Management System.  Quality is everyone's responsibility, and many leading organizations are taking this to heart.  One session at the seminar will be on the concept of extending Quality Management to the entire enterprise.  In a Life Science capacity, Quality is pervasive throughout the organization.  There is a goal of "compliance right, the first time" in order to put products and services out into the market with the goal of being as compliant as possible with each product lifecycle.  This will be a main focus topic of how automated Quality Management can provide a level of visibility that not only puts Quality Management at the forefront of everyone's agenda, but also provides the organization with a clear path to compliance.

The seminar will also feature roundtable discussions, demonstrations, and there might even be cookies - well worth the trip out to Waltham Woods.  If you're in the area, want to learn about adverse events, complaints and the holistic QMS, or you just like cookies, come out and join us.

Free Seminar
Best Practices in Complaint Handling, CAPA, and Risk-Based QMSBest Practices in Complaint Handling, CAPA, and Risk-Based QMS

In this free seminar, we will examine the different methods of utilizing Quality Management tools to manage and track Adverse Events, Complaints, eMDRs and the many aspects of Quality within Life Science organizations. We will look into these methodologies:

• Managing and tracking a Complaint Handling System
• Linking Complaint data to eMDR
• Integrating Quality Management Systems with
• Real-world Case Studies on Complaint Tracking, eMDR, Global Harmonization, and Risk-Based Quality
• Lessons learned from implementing software solutions

Register now!

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Can you tell me more about practical steps being implemented in the industry, regarding using Risk tools to sort and filter to prioritize complaints. What practical tools are used? The QSR requires all complaints to be investigated, how is this requirement addressed by companies who have huge installed base and receive thousands of complaints. I would not imagine these companies employing armies of complaints handling staff, or do they?
Posted @ Friday, April 20, 2012 5:37 PM by Remy Estera
Very interesting article, thank you, you gave me a lot of interesting information, long ago looked for something similar.
Posted @ Friday, August 03, 2012 3:44 AM by Medios EHR
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