The MDR Network Group
Wednesday, July 13, 2011
Time: 3:00 to 5:30 pm (Pacific Time)
We are having the meeting at an earlier time to allow more time for discussion.
Subject: MDR Decision Case Studies:
Warning Letters, Discussion, and FDA Perspectives
Coordinated by Chris Posin, Craig Tingley, and Eri Hirumi
Presenters:
Christine Posin, RAC
Ray Brullo, DPM, FAPWCA, Compliance Safety Officer
FDA Los Angeles District
Registration: Since this meeting will involve some special technology, we are asking that attendees register by July 5th. Please use the following hyperlink to register for this no charge meeting:
Location: Beckman Coulter, Inc. – Building A Training Ctr.
Address: 250 South Kraemer Boulevard, Brea, CA 92821
In this meeting, we will be reviewing a multitude of MDR Decision Case Studies. Actual FDA warning letter MDR observations will be discussed - with a focus on the company’s apparent interpretation of the regulation, and the FDA’s perspective on reporting the MDR. This should be a fun and informative meeting! We will be doing some voting related to MDR decisions.
BRING YOUR CELL PHONE!
If you have a case study that you would like to submit for discussion (no company names please), please send the information to Christine Posin at . The case study should include:
- Type of product;
- Relevant facts about the product failure;
- Information related to any patient event associated with the case; and
- If there were previous deaths, serious injuries (including medical or surgical intervention) associated with a previous failure of the product.
The MDR Network Group was started in May 1996. The goals of the group are to understand the FDA MDR reporting requirements (21 CFR 803), share best practices of implementing the MDR regulations, and understand common pitfalls and mistakes made by manufacturers. MDR Network meetings are open to anyone who is interested, and there is no charge to attend. OCRA membership is encouraged, but is not required.
OCRA ONLINE REGISTRATION INSTRUCTIONS
Follow the steps below to register online.
Use the Online system to receive an immediate confirmation.
Please be sure to log on or create a new user profile before registering
Once you are logged on, click on "Register for a Meeting" on the right-hand side of the page. Next click on the meeting for which you would like to register, then follow the online instructions. You will receive an immediate confirmation.
Orange County Regulatory Affairs Discussion Group
5319 University Dr., Suite 641, Irvine, CA 92612
Tel: 949-387-9046
Fax: 949-266-8461 or 949-387-9047
Email:
Driving Directions To:
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Building #A (see attached map)
Brea, CA 92822
See Map on Next Page
Directions from LA:
Take 405 S to 22 East. Then take 57 N to Imperial Blvd. Turn right onto Imperial Blvd. Go to the 5th Light and turn left onto Kraemer Blvd. Beckman Coulter will be on your right hand side.
Directions from San Diego:
Take 405 N to 55. Then take 57 N to Imperial Blvd. Turn right at the end of the exit onto Imperial Blvd. Go to the 5th Light and turn left onto Kraemer Blvd. Beckman Coulter will be on your right hand side.
Make sure to look up driving directions from your own starting point.