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US RAC Study Group
September 25-26, 2010
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Orange County Regulatory Affairs Discussion Group
Days: Saturday, September 25
And
Sunday, September 26
Times: 8:00 am – 5:00 pm
Location:Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Training Center, Building #A (entrance is off of Kraemer Blvd.)
Brea, CA 92822
Please Note: If you have attended this class in the past, we are meeting in a different building. See below for further details.
Program Manager and Host:
Eri Hirumi, Group Manager of Regulatory Affairs, Beckman Coulter, Inc.
Continental Breakfast, lunch and Refreshments will be provided at each class.
OCRA - U.S. RAC Study Group 2010
Classes run from 8:00 am – 5:00 pm on Sept 25 & 26 Located at the Beckman Coulter Brea Campus.
General Topics / Topics / 21 CFR Regulations / Dates For2010 / Confirmed Speakers
Introduction
8:00 – 10:00 /
- Introductions
- RAC Exam Overview
Introduction
Overview of Comestics / Eri Hirumi
Devices & IVDs
Pre & Post Market Regulations
11:10 - 1:00 /
- Device Submissions: PMA, 510(k)
- Device Post Approval Requirements:
- AE Reporting
- Recalls / Devices: 807, 809 & 814
Devices: 803, 806, 810, 821, 822 / SUN 09/26/2010
Devices & IVDs
Pre & Post Market / Regina O’Meara-
Lunch 12-1
GCP, IDE & IND’s
1:00 – 3:00 /
- Clinical: GCP
- Clinical IDE & IND
Devices: 812
Drugs/Biologics: 312 / SAT 09/25/2010
GCP, IDE & IND’s and Practice Exam / Ginger Clasby
Import/Export,
Labeling & Enforcement Actions
3:10 = 5:00 /
- Device Post Approval Requirements:
- Labeling Issues
-Misbranding
-Adulteration
-Import/Export
- Enforcement Action
Devices: 801, 809 & 820; FD&C 518 Drugs: 201, 202; FD&C 502 (a) Biologics: 201, 202, 600, 601.45 & 606; FD&C 501 (a), 801 & 802;
Devices: Dept of Justice / SAT 09/25/2010Import/Export,
Labeling & Enforcement Actions / Steve Lawrence -
SUNDAY 09/26/2010
Drugs & Biologics
Pre & Post-Market
8:00 – 11:00 /
- Drug & Biologics Submissions
- Drug/Biologic GMPs
- Post-Market Requirements for Drugs/Biologics:
- AE Reporting
- Recalls
- Import/Export / Drugs: 314 Biologics: 601
Drugs: 210 & 211 Biologics: 21, 211, 600, 606, 610 & 800
Drugs: 314.80 Biologics: 314.80 & 600.80 / SUN 09/26/2010
Drugs & Biologics
Pre & Post-Market / Del Stagg
GLP & QSR’s
10:10 - 12:00 /
- GLP
- Device QSR/GMPs
820 / SAT 09/25/2010
GLP & QSR’s / Kim Walker
Lunch 1-2
Practice Exam
2:00 – 4:00 /
- Practice Exam & Additional Questions or Discussions
General / Eri Hirumi
Because RAPS uses computer-based testing to administer the RAC exams, a variety of exam dates and locations are available. The RAC exams are administered twice a year in the Spring and Fall. Exam-takers can choose from available test dates within a two-month window of time in either the Spring or Fall.
For Fall 2010, the exam window is October 1 – November 30, 2010 – RAPS application deadline of August 15, 2010 and Late Fee Deadline of September 8, 2010.
For Spring 2011, the exam window is April 1 – May 31, 2011 – RAPS application deadline of February 15, 2011 and Late Fee Deadline of March 8, 2011.
The RAPS testing agency will e-mail approved applicants with information on how to register for a test date, time and location when you submit your test application to RAPS.
"Lawrence, C. Stephen" , Ginger Clasby , Del Stagg , "Regina J O'Meara" , "Kim Walker" ,
RAPS US RAC EXAM INFORMATION
Because RAPS uses computer-based testing to administer the RAC exams, a variety of exam dates and locations are available. The RAC exams are administered twice a year in the Spring and Fall. Exam-takers can choose from available test dates within a two-month window of time. For Fall 2010, the exam window is October 1 - November 30, 2010. If you are planning to take the exam this Fall, the registration deadline isSeptember 8, 2010.
The RAPS testing agency will e-mail approved applicants with information on how to register for a test date, time and location when you submit your test application to RAPS.
This study group is intended to help our members prepare for and pass the RAPS U.S. RAC exam. Anyone that intends to take the RAPS U.S. RAC exam should obtain study materials prior to attending this study group and should familiarize themselves with the exam application process via the RAPS website:
To better prepare for the exam we recommend you purchase the Fundamentals of Regulatory Affairs and the self-assessment exam. These and other preparation materials are available on the RAPS Bookstore online at:
Presentations will be emailed prior to each class allowing you to print them out and bring them with you to each class. They will not be given out at the class.
OCRA’s US RAC STUDY GROUP
September 25-26, 2010
REGISTRATIONOPTIONS
1. To register for OCRA study group, see text registration form below or
download the registration form from the OCRA website:
Online Registration (Be Sure To Log On First):
This document can also be used as a registration form.
Fax This Registration Form With Credit Card Information To:
(949) 266-8461 or (949) 387-9047
2. PayPal Payment
Date Paid:______Amount Paid:______
3. To Register With Company or Personal Check - Please complete the registration form and fax it to: (949) 266-8461 or (949) 387-9047 then make checks payable to OCRA and mail your check 10 days prior to the class to make sure it is received in time.
Orange County Regulatory Affairs Discussion Group
5319 University Dr., Suite 641, Irvine, CA 92612
Tel: 949-387-9046
Fax: 949-387-9047
Alt Fax: 949-266-8461
Email:
OCRA's non-profit Federal Tax ID# 33-0630455
4. Fax Your Registration Form With Credit Card Information To:
(949) 266-8461 or (949) 387-9046
OCRA’s US RAC STUDY GROUP REGISTRATIONFORM
Submit one copy for each person attending.Name badges and receipts will be provided at the on-site registration desk. If you would like a receipt prior to the event, please use the On-Line or Pay Pal payment option.
To Pay with Credit Card, Please check type of card:
______VISA ______MASTERCARD ______AMERICAN EXPRESS
Card #:______Expiration Date:______
Name on Card:______Signature:______
Registration Rate:
______$ 100 –OCRA Members
NOTE: OCRA is not RAPS, OCRA Membership Is Required To Attend
______$ 150 - Non-members (includes 2010 OCRA membership)
______$ 50 – Government/Students and Returning Members
Students will be asked to help with set up, tear down and possibly more tasks in exchange for the discounted rate. Student rate applies to those currently enrolled in RA or Quality courses. If you have taken this class in the past, we can offer you the $50 discounted rate for a refresher course.
Your Contact Information:
FIRST NAME: ______LAST NAME: ______
COMPANY: ______TITLE: ______
ADDRESS: ______MAIL CODE: ______
CITY: ______STATE: ______ZIP: ______
PHONE: ______FAX: ______
E-MAIL: ______
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.