October 16th, 2013

Risk Management

Orange County Regulatory Affairs Discussion Group

Thursday, November 14, 2013


Irvine Marriott

18000 Von Karman

Irvine, CA  92612





Program Managers:

Yasamin Ameri, RAC, Consultant, Quest International Consulting

Susan Wiens, Attorney, Shook, Hardy & Bacon



Steve Foster, Acting Director, Product Safety/Compliance, Abbott Medical Optics

Michelle Fujimotto, Esq., Partner, Shook, Hardy & Bacon LLP

Joely Gardner, PhD, Consultant, Human Factors Research, Inc.

Scott McCarty, Director, Operations Risk Management, Amgen

Dan Modi, Director, R&D Product Certification, Alcon (A Novartis Company)



A systematic approach to risk management is critical to all aspects of the health product lifecycle, from development to post-approval. An effective risk management program provides tools to help ensure that patients receive safe and effective products. It also provides FDA regulators with greater assurance of a company’s ability to manage the many risks inherent in the development of pharmaceuticals and medical devices. This program will provide participants with knowledge and practical methods to develop and implement a successful risk management program.


Specifically, the speakers will review important risk management guidelines and requirements, highlighting recently enacted standards, including ICH Q9, as well as IEC 60601-1 and ISO 14971. Participants will also learn how to apply risk management principles to clinical trials, supplier changes, and internal corporate communications. The importance of human factors testing in reducing risk will also be discussed.


Risk management is a fundamental and often underestimated function of business management. In today’s competitive climate, companies that effectively manage risk will have an advantage that can impact the bottom line at all levels.




Noon – 1:00 pm    Registration, Networking and Buffet Lunch


1:00 – 1:15 pm      Opening Remarks and Introductions


1:15 – 2:00 pm      Risk management in products lifecycle: Dan Modi, Alcon

This presentation will provide an overview of the practical issues and challenges to consider when implementing recently enacted standards applicable to risk management for medical devices.   The role of IEC 60601-1 in identifying and managing risks will be discussed.  The presentation will also include review of the ISO 14971 requirements and industry practices to meet them.  Risk management and quality system tie-in will also be presented.


2:00 – 2:45 pm      Supplier Risk Management: Scott McCarty, Amgen

Risks to production associated with raw material suppliers can manifest themselves in a number of ways, including (1) supply impact due to latent defects, (2) interruption of manufacturing due to material unavailability, or (3) reduced yield due to variation in product quality attributes.  Scott’s presentation will focus on strategies to improve quality, increase reliability, and reduce variability through supplier risk management.  Specific risk mitigation approaches to be discussed are tiered supplier relationships, upstream business continuity planning and evaluation, and supply chain security.


2:45 – 3:00 pm      Ice Cream Break


3:00 – 3:40 pm      THINK SMART, WRITE SMART!:

Michelle Fujimotto, Esq., Shook, Hardy & Bacon LLP

What’s lurking in your company’s emails?  As companies grow, one of the biggest threats to their livelihood is litigation.  Current communication practices put every company at risk for creating documents that may be used in litigation that can occur many years later. This is particularly true for pharmaceutical and medical device companies because of the amount and type of information they are required to record as part of the drug and device development process.  This presentation will provide information about basic product liability concepts and the documents that can negatively impact a company in litigation. For example, participants will learn about the factors that contribute to the creation of damaging documents, often referred to as “smoking guns”.  By ensuring that employees are communicating and recording information appropriately and responsibly, a company can do much to reduce potential exposure in later litigation.

3:40 – 4:30 pm      Human Factors Testing, A Risk Management Strategy: Joely Gardner, PhD, Human Factors Research, Inc.

The drug and medical device industries are seeing many more recalls based on poor consumer usability. This has prompted the FDA to be more stringent in requiring usability testing as part of safety and efficacy validation. Many companies are striving to understand the implications of these requirements for their product development and testing lifecycle. Participants in this session will learn how to implement a user-centered product development process. Topics to be covered:

  • What is usability testing?
  • How to incorporate usability testing in a risk mitigation strategy.
  • How is usability testing different from Quality Control testing?
  • What is the difference between formative and summative testing and when and how is each best used?
  • How many people need to be tested?
  • How to develop appropriate protocols to cover FDA requirements.

Human Factors testing should also be incorporated into a comprehensive clinical trial model. This portion of the presentation will discuss how human factors testing is used in a clinical trial, including examples of reliable and valid measures.

4:30 – 5:15 pm      How to Develop a Risk management plan for medical device and pharma products: Steve Foster, AMO

This presentation will provide an overview of risk management planning requirements in the medical device and pharmaceutical industries with a comparative reference to ISO14971 and ICH Q9. Common pitfalls and frequently missed opportunities of pre-market risk management planning will be discussed, followed by a survey of risk management needs typically unmet after products are launched into the market. Recommended strategies are presented to build strategic partnerships between pre-market and post-market resources for both large and small organizations.


5:15 – 5:45 pm      Q&A


About the Speakers:

Dan Modi is Director in charge of the R&D Product Certification at Alcon (A Novartis Company). His responsibilities include developing Global Regulatory STeD for Surgical instrumentation as well as managing standards certification (EMC, Product Safety, etc.).  He has wide experience in the requirements for electro-medical active devices as well as its passive accessories.  He is RAC (Regulatory Affairs Certification) for U.S, EU & Canada, NCE (RABQSA/NARTE Certified Engineer) for EMC & Product Safety, and CQA (ASQ Certified Quality Auditor).  Dan was member of the AAMI Working Group on Application of Risk Management to Medical Devices, and (Alt) Member on WG4 ISO TC 210 for ISO 14971.  Dan is also US TAG member for IEC TC 62 Electrical Equipment in Medical Practice, SC 62D Electro-medical equipment.  Dan has presented numerous private seminars and at public symposiums in the last fifteen years; He also teaches Global Regulatory Requirements course for the UCI (University of California, Irvine) Extension.


Scott McCarty has been with Amgen for 16 years and has held a variety of roles in Operations and Quality Assurance.  He is Director of Operations Risk Management, currently serving as the leader of Amgen’s Global Risk Management Network.  His prior Amgen experience includes leadership of a commercial product launch team and implementation of Amgen’s global change control system.


Prior to joining Amgen, Scott was a 20-year Navy fighter pilot, logging many aircraft carrier-based flight hours in F-4 and F-14 aircraft.  Scott holds a bachelor’s degree in Economics from Stanford University, a master’s degree in Aeronautical Engineering from the Naval Postgraduate School, and the degree of Engineer in Aerospace Engineering from the University of Southern California.


Michelle Fujimoto, Esq. is a Partner with Shook, Hardy & Bacon L.L.P. She specializes in products liability litigation, with a focus on pharmaceutical and medical device defense. She has more than 25 years of experience in complex products liability, toxic tort, and various science-driven litigations.  Her experience also includes  the defense of medical device and drug design, drug discovery, chemical exposure, breach of contract involving the divestiture of product lines, research agreements, distributor agreements and environmental remediation agreements.  She also provides risk management assessment and best practices counseling to clients ranging from start-up companies to Fortune 500 companies.


Michelle’s honors and awards include selection as one of “The Best Lawyers In America” (2011, 2013, 2014) and “The Best California Lawyers” (2012); a feature in Who’s Who Legal’s The International Who’s Who of Product Liability Defence Lawyers (2010, 2011, 2012, 2013); inclusion in Expert Guide’s Guide to the World’s Leading Product Liability Lawyers (2010); and a nomination for the Orange County Business Journal’s 2009 “Women In Business Award.”


Joely Gardner, PhD is a Consultant with Human Factors Research, Inc. She is an expert in usability testing of medical devices, software, and web-based applications. She has done usability testing and voice of customer research projects for companies such as Bespak Injectables in the UK, Mitchell Medical, Life Technologies, Quest Diagnostics Clinical Trials Division, and Cardinal Health. She also works with technology companies such as Sony to bring the voice of the customer into product development efforts.


Dr. Gardner is experienced in the process of obtaining 510(k) clearance for medical devices. She is committed to the rigor required for the effective combination of quantitative and qualitative research methodologies and the use of appropriate statistical analyses to document safety and efficacy studies for the FDA.


As a principal researcher, she is experienced at developing participant profiles and recruiting strategies, testing requirements, moderating test sessions, analyzing test data, and writing final reports for submission to the FDA. Dr. Gardner has taught “Measuring Customer Satisfaction” in the Graduate Business Extension Program at UCSD and is a part-time faculty member at California State University at Fullerton in the Certificate Program for Customer Experience and Usability. She is a current Board member for San Diego User Experience BIG (Business Interest Group) and a former Education Board Member of the American Society for Quality (ASQ).


Dr.Gardner’s undergraduate degree is in Business Administration from Simmons College in Boston. She has a Master’s Degree and a Doctoral Degree from Boston University. She is a licensed psychologist and a Fellow and Diplomate in the American Board of Medical Psychotherapists & Psychodiagnosticians.


Steve Foster

is the acting Director of Product Safety and Compliance for Abbott Medical Optics. In his current role, Steve leads post-market surveillance, complaints management, and FDA medical device reporting for Abbott Medical Optics, producer of ophthalmic medical devices that range from contact lens multipurpose solutions, cataract surgery equipment, intraocular lens implants, and laser vision correction systems more commonly known as iLASIK, CustomVue, and Wavescan. Steve is an ASQ certified biomedical auditor, six sigma black belt, software quality engineer, and manager of operational excellence. He graduated from the University of California, Irvine with a degree in Chemistry and a Masters in Healthcare Business Administration.  





OCRA Members: $155

Non Members: $205

Government and Students: $75

Participate via Webinar: $150


Registration fee includes lunch, beverages and snacks. After the meeting, electronic access to the presentations will be made for all attendees. Dress code is business casual.


 Click Here to Download the Event Flyer  





New 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.

Please use the online payment process for an immediate receipt.

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

Registration Fee includes the following: Electronic access to available presentations, continental breakfast, lunch and parking.

For a refund, please email your cancellation request to Rob Fleming (rob.fleming@yahoo.com) by November 4, 2013.



Irvine Marriott John Wayne Airport

18000 Von Karman Avenue, Irvine, CA 92612

Phone: 949-553-0100


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.


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