Orange County Regulatory Affairs Discussion Group
Invites You To Attend an Evening Meeting
Risk Management
for Regulated Industries
Wednesday, April 28, 2010
5:30 - 9:30 pm
Online Registration:
Logon first to Your Account
Location and Host:
Allergan, Inc.
2525 Dupont Drive, Irvine, CA
Presenters:
Julie Taylor, Consultant, TEC Solutions
Larry Bartkus, Supplier Quality Program Manager, ev3
Guest Panelist:
Paul Landesman, Director, Quality System and Risk Management, Allergan
Program Manager:
Gustavo Kobrin, Consultant, Strategic Regulatory Solutions
Registration fee includes snacks, drinks, free parking
and electronic access to the presentations.
Deadline to Register: April 23, 2010
Orange County Regulatory Affairs Discussion Group
Invites You To Attend an Evening Meeting
Risk Management
for Regulated Industries
Wednesday, April 28, 2010
Meeting Synopsis
The environment into which we were born and conduct our lives abound with risks. We struggle to minimize our exposure to them and insure ourselves to mitigate the negative effects if a hazard were to impact us. In order to plan for the production of safe products, we are required to reduce or eliminate risks to reasonable levels. Properly conducted risk analysis and risk management ensure that the manufacturer has done everything possible to manufacture products that are safe and meet quality requirements. In this meeting you will be exposed to methods for planning and executing risk analysis and risk management for product design, procurement and manufacturing. Regardless of the regulated industry in which work, this seminar will present you with information to identify and mitigate risks.
Schedule
5:30 - 7:00 pm
Registration/Networking with Snacks and Drinks
7:00 - 7:45 pm
Julie Taylor, Consultant, Tec Solutions
7:45 - 8:30 pm
Larry Bartkus, Supplier Quality Program Manager, ev3
8:30 - 9:00 pm
Questions and Answers
SPEAKERS and PANELIST BIOS
Julie Taylor, Consultant, TEC Solutions
Julie Taylor has over 25-years of diversified experience within the Medical Device industry. Her experience encompasses quality engineering, regulatory compliance, software quality assurance, product and process validations, environmental control laboratory, sterilization and complaints. She has been instrumental in developing and maintaining systems for CAPA, quality trending and Risk Management. Currently as an independent consultant with TEC Solutions, she enjoys developing comprehensive-yet straightforward-approaches for implementing and maintaining these quality systems. She holds a B.S. in Biomedical and Clinical Engineering from California State University, Long Beach.
Larry Bartkus, Supplier Quality Program Manager, ev3
Larry Bartkus was named ASQ Biomedical SCDG Speaker of the Year 2007-2008 and again 2008-2009 for his informative and always humorous presentations. He is currently Supplier Quality Program Manager for ev3 in Irvine. He is a Certified Quality Engineer and Six Sigma Master Black Belt with over thirty years experience in the Quality profession. He holds a degree in Chemistry from Montclair State University in New Jersey. Larry has been guest speaker at the Society of Plastic Engineers, Society of Manufacturing Engineers, APICS, OCRA, and ASQ. He is a past Chairmen of ASQ Section 702 and has served on the Executive Board for over twenty years now. He was an instructor for several CQE Refresher Courses and has conducted seminars in Process Control, Statistical Sampling, Lean, and Design of Experiments.
Paul Landesman, Director, Quality System and Risk Management, Allergan
Paul Landesman has over 25 years experience in Quality, Regulatory Affairs and Patient Safety in the Medical Device, Pharmaceutical and Bio Tech industries with companies including: Abbott Laboratories, Hospira, and Amgen. He is now with Allergan. His integrated approach has provided Quality Systems, Risk Management and Design Development practices, resulting in cycle-time reductions and enhanced compliance.
Paul holds a BS in Chemistry from the University Massachusetts-Dartmouth, a Ph.D. in Medicinal Chemistry from the University of Buffalo, and was Associate Director of the Clinical Laboratories at The Ohio State University Hospitals.
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REGISTRATION INSTRUCTIONS
Risk Management for Regulated Industries
Wednesday, April 28, 2010
Registration is Easier with OCRA’s New Website with a One Step (payment and registration) Process
From the OCRA Website:
Logon first to Your Account
If you have not yet set up a profile on the new OCRA website, follow these instructions to get setup as a user on the system. Click on the OCRA link above and then select the Members Center > Join OCRA/Renew. Please note that OCRA requires each meeting attendee to become a Member of OCRA (fee is $50 per year).
Next go to Programs in the main menu (or Upcoming Meetings Programs box on the homepage) and click on this meeting link,then click the Register Here button on the meeting details screen and follow the registration instructions.
Payment can be made online via credit card or PayPal, or off-line by mailing a company or personal check, or by faxing your credit card details. For those paying off-line (check or credit card) please register online first, then follow up by mailing the check or faxing your credit card details at least one week prior to the meeting.
MULTIPLE REGISTRATIONS:
Our system is set up for one registration at a time. It requires you to log on or create a new user profile for each person. You can also use the next page to register each person, however, electronic records will not be available to these attendees (receipt, certificate)
To Register With Company or Personal Check:
Please complete the online registration process and select the Pay Later option, then make checks payable to OCRA. If paying by check, please mail your check at least one week prior to ensure that it is received in time.
Orange County Regulatory Affairs Discussion Group
5319 University Dr., Suite 641, Irvine, CA 92612
Tel: 949-387-9046
Fax: 949-266-8461 or 949-387-9047
Email:
OCRA's non-profit Federal Tax ID# 33-0630455
Deadline to Register: April 23, 2010
Cancellation Date for Refunds: April 23, 2010
If you have reserved a space but do not attend, your payment MUST be remitted.
Group Registrations:
Please use the next page
to register multiple people from your company.
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OCRA OFFLINE and GROUP REGISTRATION FORM
PAGE 1 OF 2
Risk Management for Regulated Industries
Wednesday, April 28, 2010
ONLINE REGISTRATION:
Please register online for an immediate receipt and confirmation:
Logon first to Your Account
This document can also be used as a registration form. Fax This One Page Registration Form With Credit Card Information To: (949) 266-8461 or (949) 387-9047. Please note that receipts will not be available until the day of the meeting if you use the offline registration process.
Please check type of card:
______VISA ______MASTERCARD ______AMERICAN EXPRESS
Card #:______Expiration Date:______
Name on Card:______Signature:______
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. Submit one copy for each person attending.
Registration Rate is:
______$ 50–OCRA Members
______$ 100 - Non-members (includes OCRAmembership through 12-31-10)
______$ 25 - Government and students*
______As the Host Facility, There Is No Fee for Allergan Employees
*Student Rate is for Full-time students only. Student ID and copy of current class schedule required to register.
OCRA OFFLINE and GROUP REGISTRATION FORM
PAGE 2 OF 2
Risk Management for Regulated Industries
Wednesday, April 28, 2010
ONLINE REGISTRATION:
Please register online for an immediate receipt and confirmation:
Logon first to Your Account
Please Supply Contact Information for Each Attendee:
FIRST NAME: ______
LAST NAME: ______
COMPANY: ______
E-MAIL: ______
TITLE: ______
ADDRESS: ______
MAIL CODE: ______
CITY: ______
STATE: ______
ZIP: ______
PHONE: ______
FAX: ______
DRIVING DIRECTIONS:
Allergan, Inc.
2525 Dupont Drive
Irvine, CA 92623
Driving instruction from Los Angeles
Take I-5 South
Transition to I-605 South
Transition to I-405 South
Exit Jamboree Road
Turn right at Jamboree Road
Turn right at Dupont Drive
Turn RIGHT into driveway from Dupont (after passing Teller Avenue)
Present photo ID to the security guard for identification
Follow the on-campus guard instruction and sign for parking
Driving instruction from San Diego
Take I-5 North
Take the I-405 N exit toward Long Beach
Exit Jamboree Road
Turn left at Jamboree Road
Turn right at Dupont Drive
Turn RIGHT into driveway from Dupont (after passing Teller Avenue)
Present photo ID to the security guard for identification
Follow the on-campus guard instruction and sign for parking
Driving Directions and Security Instructions
It is important to bring a photo ID (preferably a Driver License) for identification. You will need to present this at the security gate before entering the facility. Please inform the guard that you are attending the OCRA Meeting. Note: This security policy will be strictly enforced.
It is recommended that you look up driving directions from your own starting point.