Wednesday, August 4, 2010

Medical Device Complaint Handling: What the New FDA Wants to See Today (and How to Show Them)

Below are excerpts from three warning letters issued this year citing medical device complaint handling failures - do you see a pattern?

"Out of the 29 complaints reviewed...18 complaints did not have a documented corrective action; and all 29 did not document the evaluation to determine if the event was reportable to FDA under 21 CFR Part 803."

"Your complaint record... did not include information to show whether an investigation was conducted, what caused the material to not set properly, and whether any CAPA was implemented as required by your written procedure for handling complaints."

"The complaints pointed out that the wrong pipette was included...You verified that the wrong pipettes were included in the kit, but did not perform any follow up investigation to determine why the wrong pipettes were packaged or if the problem could be more widespread."

The new FDA is consistently emphasizing investigation of and follow-up on complaints - not just documenting them.

In this 90 minute webinar, expert consultant Judith Andrews, Ph.D. will show how to ensure your complaint handling systems are proactive, effective, and compliant.

After this program, you will know:

The first thing you should do when a possible complaint comes in
How to determine if a complaint should be investigated
Strategies to prevent the 7 most common complaint failures
9 channels a complaint can come through, and how you should monitor them
6 elements to include in every complaint file
When complaint coincidences become trends, and how they inform investigations
How to ensure your complaint handling integrates fully into your overall CAPA program
Documentation that effectively shows investigators you are handling complaints successfully

Judith will also answer your team's questions in the Q&A session.

Who should attend...

Regulatory affairs and compliance staff
GMP and Quality Systems auditors
QA and QC personnel
Executive management
Risk management specialists
Training personnel

For one low price, you and your entire team from one location can take part in this fast-paced, insightful webinar. Best of all, you'll be able to connect personally with our panelists when we open up the phone lines for live Q & A.

SPEAKERS

Judith Andrews
Director, Quality and Compliance Services
Medical Device Consultants, Inc..

Judith Andrews, Ph.D., is Director, Quality and Compliance Services at Medical Device Consultants, Inc. She has more than twenty years of hands-on experience in the FDA regulation of medical devices. She has held positions in product development, manufacturing, quality control and quality assurance at several companies including a fortune 500 company and several start-up firms. Her demonstrated expertise in developing, implementing, and auditing quality systems, together with a “value-added” approach, is a strong fit for medical device manufacturers seeking to comply with QSR, ISO 13485:2003, MDD, IVDD, AIMD or Canadian Medical Device Regulation. She assists clients with recalls, U.S. and EU medical device reporting, and FDA 483s and warning letters.

Judy holds a Ph.D. in chemistry from Case Western Reserve University and an M.B.A. from Simmons Graduate School of Management. She is a certified biomedical auditor and is Regulatory Affairs Certified. She serves on the board of the New England chapter of the ASQ Biomedical Division and speaks regularly at industry and professional conferences, seminars and webinars.

Webinar Details

DATE: Wednesday, August 4, 2010
TIME: 1:00 PM ET • 11:00 AM MT • 10:00 AM PT
DURATION: 90 Minutes

Benefits

What does registration get me?

One (1) phone line, for you alone, or around which to gather your team(s). Toll-free in the U.S. only.
One (1) password to a website on which you'll be taken through the presenters' slides as they speak to them.
An interactive Q&A round with speakers by phone and electronic submission.
The insight you've come to expect and respect from Elsevier Business Intelligence and our guest speakers.

What are the unique benefits of a webinar?

Convenience—and lower cost. Your entire team can listen in one room. No travel required!
A team approach. You've often wanted to have everyone on your team getting the same knowledge and insight you derive from physical conferences. Now you can.
Interactivity. You're remote, but not removed. Our webinars let you ask the important, burning, controversial questions of our speakers that you'd be able to pose at a physical conference.
Flexibility. Want to be able to review what you learn? No problem ... just register for the live webinar PLUS a digital copy of the entire event to listen to at your convenience. Interested in the topic but have a scheduling conflict? Don't worry — the recording is available for purchase at any time

SUPPORTING PUBLICATIONS

REGISTRATION

Buy the recording/transcript: Click here for just the recorded webinar with the complete transcript, $349
Register by email: custcare@elsevier.com
Register by phone: 1 (800) 332-2181(U.S.) / +1 (908) 547-2159 (non- U.S.)

Webinar Cancellation Policy: No refunds or credits will be given one week prior to the scheduled webinar, or after the webinar presentation materials and access instructions have been sent to participants. In lieu of cancellation, you may substitute another delegate from your company as a replacement.