Medical Device Reporting Inspections and Exemptions
Medical Device Reporting Event: Inspections and Exemptions
Orange County Regulatory Affairs Discussion Group (OCRA)
Wednesday, November 7, 2012
3:00 – 7:00 pm
18000 Von Karman, Irvine, CA 92612
Paul Kramsky, President, Rockin’ Regulatory, Inc.
Christine Posin, RAC, Consultant
Registration fee includes snacks, parking and access to electronic presentations (if approved by speaker for distribution).
3:00 – 3:30 pm
3:30 – 4:30 pm
Vicki Anderson, Compliance Officer, US Food and Drug Administration Los Angeles District Office
Vickie Anderson will be providing information on FDA inspections – with a twist. She will be focusing on FDA inspections in the product complaint and MDR areas. This session will give you an idea of what to expect in these areas during an FDA inspection, and how to better prepare in an effort of continual compliance.
4:30 – 5:30 pm
William Huff, Public Health Analyst
CDRH, US Food and Drug Administration
William Huff will be providing information regarding exemption options for the Alternative Summary Reporting (ASR) program. He will provide the guidelines for what type of products and issues are good candidates, how to get started, and what type of information the FDA expects when the manufacturer applies for approval. Mr. Huff is the Exemption Coordinator for the MDR Policy Branch and is the contact person for the ASR program.
For those in the unfortunate circumstance of finding that they have not reported MDRs as required, and the number of MDRs is significant, Mr. Huff will provide information on Retrospective Summary Reporting and the possibility for a reporting exemption to allow a summary of the reports.
William Huff is currently a Public Health Analyst in the Medical Device Reporting Branch of the Division of Postmarket Surveillance at the Center for Devices and Radiological Health (CDRH), FDA. The Branch is responsible for interpretation of the Medical Device Reporting (MDR) Regulation, determines when events are reportable under MDR, drafts guidance documents, provides educational outreach and manages the exemption program. Mr. Huff has worked for the Center for Devices and Radiological Health for 25 years.
5:30 – 6:30 pm
Chris Posin, RAC, Consultant
Chris Posin will cover common mistakes in MDR decision making and warning letter observations related to MDR reporting. She will also provide MDR case studies with Q&A.
If you have any specific questions that you would like to discuss, please forward them to firstname.lastname@example.org.
Chris Posin is a consultant with over 30 years experience, specializing in regulatory and quality assurance compliance. Formerly, she was the Global Director of Product Surveillance at Bausch & Lomb Surgical, Inc. She graduated from Bowling Green State University with a Bachelor of Science degree, majoring in Biology. Prior to her career in the medical device industry, she was a health care professional in the cardiopulmonary field.
In 1996, Ms. Posin organized and now facilitates OCRA’s MDR Network, a professional network group focused on MDR reporting. The network group is composed of representatives from over 48 medical device manufacturer and user facilities who work with a designated liaison from the LA District FDA. The MDR Network Group received the National Performance Review Hammer Award from Al Gore in 1999 as part of his program for innovations in government.
She is a past president of OCRA and has served as the Chair for the FDA/OCRA Educational Conference.
6:30 – 7:00 pm
$135 OCRA Members
$185 Non Members
(includes OCRA Membership for one year)
$75 Student/Government Rate
Be sure to log on or create a new user profile before registering
Our system is set up for one registration at a time. To register multiple people from your company, you can simplify the process by faxing us a cover page on your company letterhead listing the names of your attendees along with their title and email address.
Log on to the OCRA Web site with your username and password or create a new user profile:
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.
If paying by personal or company check:
Please submit the online registration form. Mail your check made payable to OCRA to the following address:
Orange County Regulatory Affairs Discussion Group
5319 University Dr., Suite 641, Irvine, CA 92612
Fax: 949-266-8461 or 949-387-9047
OCRA’s non-profit Federal Tax ID# 33-0630455
NOTE: We will ask for a credit card payment for any checks not received by the meeting date
For a refund, please cancel by replying to this email by November 1, 2012
If you have reserved a space but do not attend, your payment MUST be remitted.
Irvine Marriott John Wayne Airport
18000 Von Karman Avenue, Irvine, CA 92612
From OC/John Wayne Airport:
Exit airport on Michelson Drive. Go straight to Von Karman Avenue and turn Left onto Von Karman Avenue. Turn Right onto Quartz and Left at the stop sign. The Marriott Hotel is on the left hand side.
From Long Beach Airport
or LAX – Los Angeles International Airport:
Take 405 South (San Diego Freeway). Exit Jamboree and turn Right off ramp. Turn Right onto Michelson Drive and Right onto Von Karman Avenue. Turn Right onto Quartz and Left at the stop sign. The Marriott Hotel is on the left hand side.
From Ontario International Airport:
Take 10 West (San Bernardino Freeway) to the 57 South (Orange Freeway). Take 57 South to the 5 South (Santa Ana Freeway). Take 5 South to the 55 South (Newport Beach Freeway) and then to 405 South (San Diego Freeway). Exit Jamboree, turn Right off ramp. Right onto Michelson Drive and Right onto Von Karman Avenue. Turn Right onto Quartz and Left at the stop sign. The Marriott Hotel is on the left hand side.
From Downtown Los Angeles:
Take 5 South (Santa Ana Freeway) to 55 South (Newport Beach Freeway). Take 55 South to 405 South (San Diego Freeway). Exit Jamboree and turn Right off the ramp. Turn Right onto Michelson Drive and Right onto Von Karman Avenue. Turn Right onto Quartz and Left at the stop sign. The Marriott Hotel is on the left hand side.
From San Diego:
Take 5 North (Santa Ana Freeway) to 405 North (San Diego Freeway). Exit Jamboree and turn Left off the ramp. Turn Right onto Michelson Drive and Right onto Von Karman Avenue. Turn Right onto Quartz and Left at the stop sign. The Marriott Hotel is on the left hand side.
From San Bernardino/Riverside:
Take 91 West (Riverside Freeway) to 55 South Freeway (Newport Beach Freeway). Take 55 south to 405 South Freeway (San Diego Freeway). Exit Jamboree Road, turn right off ramp. Turn Right onto Michelson Drive and Right onto Von Karman Avenue. Turn Right onto Quartz and Left at the stop sign. The Marriott Hotel is on the left hand side.
It is recommended that you look up driving directions from your own starting point.
Attention To Detail
5319 University Dr., Suite 641
Irvine, CA 92612
Alt Fax: 949-266-8461