Tuesday, August 31, 2010

Responding to Form 483s: Learn from a Former FDA Device Investigator

Despite your preparations, an investigator just handed you a Form 483. You have limited time to correct all problems and even less time to create a response that will satisfy the FDA.

The next few steps you take will make the difference between receiving a warning letter and escaping the public scrutiny and embarrassment.

In 90 minutes, the lead of Nixon Peabody’s FDA practice and former FDA investigator, Seth Mailhot, will teach you how to respond efficiently to a Form 483. He will explain what actions to take from your first response through completion and follow-up.

During this webinar, you will learn:

How to respond on site to an accurate observation
What to say when you think the investigator is wrong
How to develop a viable remediation plan quickly
7 things NOT to say in your Form 483 response – unless you want a Warning Letter
4 statements the FDA loves to hear — and how to back them up with facts

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

Who should attend...

Auditors
Executives
QA/QC managers
Compliance officers
Regulatory affairs professionals
General and corporate counsel

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.

SPEAKER

Seth A. Mailhot
Counsel
Nixon Peabody LLP

Seth Mailhot is the lead attorney for Nixon Peabody's FDA Regulatory practice, and a member of its Life Sciences and Health Care practices. His experience includes enforcement and recall matters, preparation and prosecution of FDA pre-market submissions such as 510(k)s, PMAs, IDEs and pre-IDE), and compliance with quality, regulatory, and manufacturing requirements. Seth previously spent 14 years with the FDA, serving in a variety of capacities overseeing activities of pharmaceutical, biologic, medical device, food, cosmetic and dietary supplement companies. He was a Level II certified medical device investigator and conducted foreign and domestic inspections.

Seth's additional background as a patent attorney who has worked on major intellectual property litigation cases allows him to offer insights about how regulatory issues can impact.

Webinar Details

DATE: Tuesday, August 31, 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

$349 - Recorded Webinar with Complete Transcript, click here
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.