April 8th, 2015

Risk Based Auditing Fundamentals

You are Invited to an Evening Meeting


Risk Based Auditing Fundamentals


Orange County Regulatory Affairs Discussion Group


Tuesday, April 21, 2015
4:00 – 7:00 pm

Auditing is a part of life, almost irrespective of the industry.

We can make it as hard as we want, trading efficiency and effectiveness for a check box in the done column.

This program will provide an overview to a risk-based approach to the audit process plus an auditing process overview.


Alcon Laboratories, Inc. – New Venue

15800 Alton Parkway
Irvine, California 92618


Program Manager and Speaker:  

James R. Lusk, Principal, Quality Systems International

About the Speaker

James (Rusty) Lusk has over 37 years of experience in regulated and non-regulated industries ranging from early-stage development to Fortune 100 companies. He has held senior management positions in disciplines such as Regulatory, Quality, Clinical Programs, and New Business Development. He is currently a Principal with Quality Systems International; a multidiscipline consulting company serving ISO/EN and FDA regulated industries. He is also co-founder of LifePulse, LLC, an early-stage medical device company and co-inventor of a non-invasive device intended to delay or reverse cardiovascular disease and improve quality of life.


He is Past President of Orange County Regulatory Affairs (OCRA) Discussion Group, a nonprofit organization with the mission of educating the regulatory professionals.


He has an MBA from Pepperdine University, a BS in Biological Sciences from The University of California, Irvine and an AA in Electronics from Orange Coast College.


He is has the following certifications: Regulatory Affairs Professional (RAC both US & EU), American Society for Quality: CMQ/OE, CQE, CQA, CQAHACCP and Lead Auditor, Quality Management Systems, RABQSA.



4:00 – 5:00 pm

Registration, Networking and Appetizers


5:00 – 7:00 pm

Presentation and Q&A




OCRA Members: $50

Non Members: $100

*Students and Government: $25


 Click Here to Download the Event Flyer 


Online Registration Instructions:

Step 1:   

Click on this link:


Step 2:   

Immediately log in with your username and password OR Create a new account by selecting “Register” on the top right hand side. If you are not an OCRA Member, it will ask you to join. Please keep in mind that to attend any OCRA meeting, we require you to become a Member.

Step 3:   

Once you have logged on (and paid for membership) select the meeting you would like to attend and complete the registration process by filling in the appropriate fields.

PAYMENT OPTIONS To Pay With Credit Card

Register and pay online as described above.  If you prefer to fax your registration form, please click on the form below to download it.  Complete the form and fax it with your credit card payment to: 949-266-8461


Click here to download the registration form

To Pay With Company or Personal Check

Please register online (see instructions above). Then select the “Pay Off-Line” payment method and select “Company Check” or “Personal Check”. Make sure to mail your check at least 10 days prior to the conference to ensure it is receive in time. Only paid attendees will be able to attend. If a check has not been received, you will be asked to provide a credit card as a hold until the check is received.


Mail your check payable to:

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:  ksyre@cox.net

OCRA’s non-profit Federal Tax ID# 33-0630455

To Pay using PayPal

When registering online PayPal is one of the payment options.

PayPal requires that you set up an account with them prior to making payment for this meeting. Once you receive confirmation of your new account, then you can register for this meeting.

The Student Rate is for individuals enrolled full time in a Regulatory or Quality related academic program at an accredited institution. This rate is not available for online registration. The Student Rate does not apply to working professionals taking one or two courses on the side. To qualify, please fax your registration form with student ID and copy of current class schedule to 949-266-8461. Final eligibility determined by OCRA.

RECEIPTS FOR PAYMENT Please use the online payment process for an immediate receipt.

Name badges and materials will be provided at the on-site registration desk.

Cancellations For a refund, please email your cancellation request to Rob Fleming (rob.fleming@yahoo.com) by April 14, 2015.

NOTE:  We will ask for a credit card payment for any checks not received by the meeting date. If you have reserved a space but do not attend, your payment MUST be remitted.


Alcon Laboratories 

15800 Alton Pkwy 

Irvine CA 92618



Directions from LA:

Take I-405 S to Exit 3 (in Irvine).

Take ramp right and follow signs for Shady Cyn Dr/Sand Cyn Ave.

Turn left onto Sand Canyon Ave.

Turn right onto Alton Pkwy.

Go 0.9 miles and arrive at 15800 Alton Pkwy, Irvine.

The last intersection is Telemetry.

(If you reach Banting, you’ve gone too far.)


Directions from San Diego:

Take I-5 N to Exit 94B.

Take ramp right and look for signs for Alton Pkwy.

Turn left onto Alton Pkwy.

Make a u-turn at Telemetry and arrive 15800 Alton Pkwy.

(If you reach Banting, you’ve gone too far.)


We recommend you look up driving directions from your own starting point.



Kimberly Syre

Attention To Detail
5319 University Dr., Suite 641
Irvine, CA  92612
Tel:    949-387-9046
Fax:    949-387-9047
Alt Fax:    949-266-8461
Email:    ksyre@cox.net