the 15th annual fda-ocra educational conference sustainable

FDA CentersFDA Los Angeles District Office

AndOrange County Regulatory Affairs Discussion Group

Present

The 15th AnnualFDA-OCRA Educational Conference

Sustainable Regulatory Practicesat Irvine Marriott

June 6-7, 2012See These Pages ForMore Information:

Conference Information

About OCRAPage 2

JUNE 6 SESSIONSAM Plenary SessionsPage 3

PM Plenary SessionsPage 4

JUNE 7 SESSIONSBreakfast Meeting Page 5

AM Plenary SessionsPage 6

BREAKOUTS Devices & IVDsPage 7

Drugs/Biologics/OTC/GenericsPage 8

Dietary SupplementsPage 9

Registration FormsPages 10-12

Driving Directions andHotel InformationPage 13

List of Acronyms UsedIn this DocumentPage 14

The FDA-OCRA Educational Conference is a unique event co-sponsored by the FDA and OCRA, that affords you maximum interaction with both Los Angeles District and Washing-ton-based FDA personnel. Over the years, the collaborative efforts of FDA and OCRA have brought FDA and Industry staff together for this Educational Conference.

Who Should Attend• Regulatory Affairs/Compliance • Clinical Affairs/Auditors• Legal Staff • Quality Affairs/Quality Control • Marketing & Advertising • Product Development• Consultants & Analysts • Operations & Management

Plenary topics: • Key Initiatives and Concerns at FDA Centers• Global Updates - New Regulatory Challenges and Hot Topics• Global Enforcement and Compliance Challenges• Bringing Quality into Risk Management• Environmentally Conscientious Initiatives for Medical Product Manufacturing• How to Decrease Your Leadership’s Professional Liability• Social Media, Marketing and Off-Label Promotion• Q&A Panel Sessions with all Speakers

Three Separate Breakout Sessions: 1. Medical Devices & IVDs: CDRH Update: 510(k) Review Process/De Novo Reviews/Pre-IDE and more Developing Medical Device Software Using the Team Software Process Opening an IDE: What is Changing, Current Expectations, Impact of New Guidances

2. Drugs/Biologics/OTC/Generics: Hot Topics in Drugs and Biologics Quality by Design: FDA’s Approach and the Real World of QbD Quality by Design: Process Mapping, Risk Assessment, QbD for Manufacturing

3. Dietary Supplements: FDA Update and Hot Topics for Dietary Supplements GMPs for Dietary Supplements with Focus on Top Areas of Non-Compliance Quality Assurance and Quality Control Issues

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The 15th Annual FDA-OCRA Educational ConferenceSustainable Regulatory Practices

June 6-7, 2012

See These Pages ForMore Information:

Conference InformationPage 1

About OCRA











Conference Chairs:Alonza E. Cruse, BS, District Director, FDA Los Angeles DistrictEri Hirumi, RAC, Regulatory Affairs Manager, Beckman Coulter, Inc.

Conference Location: Irvine Marriott18000 Von Karman Avenue, Irvine, CA 92612 (949) 553-0100

Annual Conference Committee:Daphne Berry, RA/QA Professional, WV Hellums ConsultingCindy Fisher, PhD, RAC, Associate Director, Regulatory Affairs, Vical IncorporatedAmy Gonzales, Sr. Corporate Quality Compliance Associate, Amgen Inc.Niedre Heckman, RA/QA Consultant, Global Quality Outcomes, LLCGus Kobrin, President, Strategic Regulatory Solutions, Inc.Paul Kramsky, President, Rockin’ Regulatory, Inc.Helene Lamielle, MD, Sr. Director Clinical Development, Allergan MedicalJames “Rusty” Lusk, RAC, Principal, Quality Systems InternationalPhyllis Morey, ConsultantRegina O’Meara, IVD Regulatory ConsultantRuchika Raval, RAC, Global Biopharmaceutical Regulations, Inc.Helene Spencer, Consultant, ClinReg Consulting Services, Inc.Michael A. Swit, Esq., Special Counsel, San Diego Office, Duane Morris LLPMichael J. Wagner, Esq., Regulatory Counsel, Focus Diagnostics, Inc.Kim Walker, MS, RAC, Global RA & QA Consultant, Kim Walker ConsultingVicki Whitsitt, Manager, Scientific and Regulatory Affairs, Natural Products Association

About OCRAOCRA, Orange County Regulatory Affairs Discussion Group, is a non-profit volunteer organization composed of Regulatory Affairs professionals from the Southern California area who are interested in participating in educational programs and networking with one another. Our membership includes individuals who work in Life Sciences industries such as medical devices, pharmaceuticals, biologics, IVD, dietary supplement, food and cosmetics.

OCRA has over 850 members representing more than 225 companies in Orange County and sur-rounding areas. Our members represent companies of all sizes and complexities.

OCRA meetings provide an educational forum and a means for the regulatory community to network. While our focus is regulatory in nature, our programs have also provided timely information for indi-viduals involved in Engineering (software validation and product development), Marketing (advertising and labeling), Quality (Quality System Regulation), and other related fields.

OCRA Board of Directors:President - Cindy Fisher, PhD, RAC, Associate Director, Regulatory Affairs, Vical Inc.President Elect - Ginger Clasby, VP Clinical & Regulatory Affairs, Transcend Medical, Inc.Treasurer - Helene Spencer, Consultant, ClinReg Consulting Services, Inc.Secretary - Regina O’Meara, IVD Regulatory ConsultantAnnual Conference Chair - Eri Hirumi, RAC, Regulatory Affairs Manager, Beckman CoulterMembership Chair - Gus Kobrin, President, Strategic Regulatory Solutions, Inc.Member Benefits Chair - Helene Lamielle, MD, Sr. Director Clinical Development, Allergan MedicalProfessional Organization Liaison - C. Stephen Lawrence, OCRA Founding MemberWeb Site Development Chair - James “Rusty” Lusk, Principal, Quality Systems InternationalEducational/Professional Development - Ruchika Raval, RAC, Global Biopharmaceutical RegulationsProgram Committee - Vicki Whitsitt, Mgr, Scientific/Regulatory Affairs, Natural Products AssociationPast President - Tania Hoffman, RSMS, Regulatory Affairs, Spectrum Pharmaceutical

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About OCRAPage 2

JUNE 6 SESSIONSAM Plenary Sessions










7:00 - 8:00 am Registration and Continental Breakfast

8:00 - 8:30 am Opening Remarks by Conference Chairs and OCRA President Alonza E. Cruse, B.S., District Director, FDA Los Angeles District Eri Hirumi, RAC, Regulatory Affairs Manager, Beckman Coulter, Inc. Cindy Fisher, PhD, RAC, Associate Director, Regulatory Affairs, Vical Inc.

8:30 - 10:15 am Keynote Addresses: Key Initiatives at FDA Centers Moderator: Regina O’MearaSpeakers: Key Initiatives at CDRH - Alberto Gutierrez, PhD, Director, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), FDA Key Initiatives at CBER - Robert Yetter, Assoc. Director for Review Management, Center for Biologics Evaluation and Research, FDA Key Initiatives at CFSAN - Daniel Fabricant, PhD, Director, Division of Dietary Supplement Programs, FDA

10:15 am Break

10:30 am - Noon Global Updates - New Regulatory Challenges and Hot Topics Moderator: Kim Walker, MS, RAC Speakers: Ann Ferriter, Acting Director of Risk Management, CDRH, FDA Leslie Eastman, Senior Project Manager, Eastman Enterprises

This session will cover the following global new regulatory challenges and hot topics:1. How to expand the Risk Assessment Process and Information to Fit Into a Total Product Lifecycle Management Process - Regulatory Agen-cies are actively making the links between monitoring post market is-sues to help evaluate pre market clearance/approvals. So what should industry be aware of about recalls in their product areas, what informa-tion is shared and what information can industry provide FDA about the recalls to support the Total Product Lifecycle Management Process.2. Got Chemicals? It’s Not Just About OSHA and DOT Anymore - The Globally Harmonized System of Classification and Labeling of Hazard-ous Chemicals (GHS) was adopted in December 2002 by three major international organizations: United Nations Committee of Experts on Transport of Dangerous Goods (UNCETDG), International Labor Or-ganization (ILO), and the Organization for Economic Cooperation and Development (OECD). The goal is to provide a consistent approach to manage and communicate chemical hazards across the world and across industries. Transposition and implementation of these new regulations have started worldwide and a critical implementation due date is June 2015. This session will provide a global overview of the implementation deadlines, description of the changing elements, and what may be the immediate impact to drug, device, biologic, and dietary supplement manufacturers and distributors.

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SCHEDULEWednesday Morning

June 6, 2012


June 6-7, 2012



About OCRAPage 2


PM Plenary Sessions









Noon - 1:15 pm Networking Lunch OCRA Update from Cindy Fisher, PhD, OCRA President

1:15 - 3:00 pm Global Enforcement and Compliance ChallengesModerator: Kim Walker, MS, RAC Speakers: Katherine Jacobitz, Sr. Supervisor Regulatory Officer, FDA LA District Hugo Cornejo, Drug & Consumer Product Safety Section Chief, State of CA Food and Drug Branch Evangeline D. Loh, PhD, RAC, VP Global RA, Emergo Group

This session will cover the following global enforcement and compliance challenges1. FDA 483 and Warning Letter Trends – Discussion on current enforce-ment trends locally and nationally with a discussion on upcoming hot topics for FDA investigators. What can industry do to improve?2. State of CA FDB – Inspection trends for Drugs, Biologics, Dietary Supplements, and Devices with a discussion on upcoming hot topics for FDB investigators? What can industry do to improve? Under what circumstances and how often does FDB coordinate with FDA?3. EU Vigilance and Inspection Trends - Discussion on current vigilance and enforcement trends within the EU with a discussion on upcoming hot topics. What can industry do to improve?

3:00 pm Break

3:15 - 4:30 pm Bringing Quality into Risk ManagementModerator: Cindy Fisher, PhD, RACSpeakers: Ann Ferriter, Acting Director of Risk Management, CDRH, FDA Brian Weller, RAC, Sr. Consultant, Certified Compliance Solutions 1. Introduction to Safety Risk Management and its potential benefit to Operational Risk Management in Life Science companies. 2. Sharing Risk Management use within FDA for site selection, complaint triage, import sampling, and recall classification. 3. Sharing Risk Management within companies both horizontally and vertically, from technicians to management, especially when merging the pharmaceutical and medical device arenas to create drug delivery or combination products. 4:30 - 5:15 pm End of Day Open Panel Discussion with All SpeakersModerator: James “Rusty” Lusk, RAC

5:15 - 8:00 pm After Conference Reception - OCRA’s Member Appreciation Night All attendees invited at no additional cost

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SCHEDULEWednesday Afternoon

June 6, 2012


June 6-7, 2012



About OCRAPage 2



JUNE 7 SESSIONSBreakfast Meeting








7:00 - 8:00 am Breakfast Session Kermit Was Wrong - It is easy to be GREEN! Environmentally Conscientious Initiatives for Medical Product ManufacturingModerator: Kim Walker, MS, RACSpeakers: Alicia Chu, LEED AP O+M, Sustainability Advisor Healthy Buildings Lena Ohta, CRM, LEED AP, GPR, CGBP, Sustainability Advisor Healthy Buildings Lance Williams, PhD, LEED AP, Executive Vice President/Partner Okapi Sustainability, Inc.

This session will address the following topics:

1. How to integrate environmentally conscious initiatives into medical product manufacturing.

2. What regulations already exist and how can you comply with them in a cost-friendly way?

3. Is it possible to be green and save money?

Alicia Chu will provide a top level overview of current green sustain-ability practices and the LEED certification process. She will provide real world examples of how businesses have incorporated these practices successfully.

Lena Ohta will discuss how sustainability practices can help organiza-tions save money using real world examples.

Dr. Lance Williams will discuss regulatory hurdles and government incentives related to green initiatives. He will also address how youas an individual can advocate for these changes internally and how becoming a green advocate can provide professional growth opportu-nities.

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SCHEDULEThursday MorningBreakfast Session

June 7, 2012


June 6-7, 2012



About OCRAPage 2




AM Plenary Sessions







6

SCHEDULEThursday MorningPlenary Sessions

June 7, 2012

8:00 - 9:00 am How to Decrease Your Leadership’s Professional LiabilityModerator: Esther Y. Kim, Esq., Senior Corporate Counsel Quest DiagnosticsSpeaker: Michael A. Swit, Esq., Special Counsel, San Diego Office, Duane Morris LLP

How do you look in stripes? Corporate officer doctrine, criminal pros-ecution and exclusion from federal programs are drastic enforcement options that are becoming a lot more common. You’d be surprised at what actions can make you unemployable in the medical products industry. Throw in whistleblower laws and you can have the perfect storm. Get advice on how to decrease your and your leadership’s professional liability.

9:00 - 10:15 am Social Media, Marketing & Off-Label Promotion Panel DiscussionModerator: Paul KramskySpeakers: Ellen J. Flannery, Partner, Covington & Burling LLP Toni M. Stifano, Office of Compliance, Promotion and Advertising Policy Staff, CDRH, FDA Panelist: Daniel Fabricant, PhD, Director, Division of Dietary Supplement Programs, CFSAN, FDA

How social media have put pressure on companies to adopt sustain-able (environmental) practices so that their reputations remain clean.

Marketing issues are costing companies a fortune in fines. Hear about FDA’s concerns about off-label promotion and other priorities. Get guidance on how to comply and hear about new initiatives. Following the two presentations, a panel discussion will be held.

10:15 am Break

10:30 am Breakout Sessions Begin: Medical Devices & IVDsDrugs, Biologics, OTC and GenericsDietary Supplements(see schedule on next three pages)

Noon - 1:15 pm Lunch OCRA Member Awards

2:45 pm Break

4:15 - 5:00 pm End of Day Open Panel Discussion With All Speakers from Both DaysModerator: Eri Hirumi, RAC


June 6-7, 2012



About OCRAPage 2





BREAKOUTS Devices & IVDs






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10:30 am - Noon CDRH Update: 510(k) Review Process/De Novo Reviews/Pre-IDE Moderator: Michael Wagner, Esq.Speakers: Ellen J. Flannery, Partner, Covington & Burling LLP Alberto Gutierrez, PhD, Director, OIVD, FDA

CDRH is in the forefront of updating the 510(k) review process, and expanding the types of products that FDA regulates including tier triage, streamlining de novo reviews and pre-IDE meetings, and others. OIVD is a key partner is regulating mobile phone apps, and has been actively looking at regulating lab developed tests, research-use-only products, direct-to-consumer testing and others. Want to know what’s on the cutting edge? Find out what products are regulated, how to foster dialog with the reviewer, and how to get quicker clearance.

1:15 - 2:45 pm Developing Medical Device Software Using Team Software Process and Europe: What’s Happening and What’s Next?Moderator: Phyllis MoreySpeakers: Carl Wyrwa, CW Software Solutions, Inc. Jaap Laufer, MD, PharmD, VP Public/Regulatory Affairs, Emergo Group

Carl Wyrwa - Developing software for medical devices is a very challenging undertaking. The quality of the software must be extremely high to meet the demands of providing safe and effective products involved in the critical care of patients. The Team Software Process (TSP) has recently been rated as the top software development method for developing medium and large scale software systems. This presen-tation will describe how the TSP can help medical device companies developing software achieve superior software quality and schedule predictability. The use of TSP also helps organizations effectively meet many of the compliance requirements of ANSI/AAMI/IEC 62304 and FDA Guidance. Jaap Laufer - The regulatory environment in Europe is in a state of fast flux. The PIP scandal, reinforced by often incorrect media reports, deeply impacts the implementation of the current Directive as well as the development of the new EU regulation for medical devices. Other hot topics are the new approach to clinical evaluation and investiga-tion, new requirements for PMS and post-market clinical follow-up, how these matters impact the review by Notified Bodies, and a number of 2011-2012 international case studies.

3:00 - 4:15 pm Opening an IDE: What is Changing, Current Expectations from the Agency, Impact of New GuidancesModerator: Helene Lamielle, M.D.Speakers: Alberto Gutierrez, PhD, Director, OIVD, FDA Marianne Thornton, Principal, Alpha IRBPanelists: Judy Gordon, DVM, ClinReg Consulting; Jone Hsia, RAC, AcuFocus; Omid Khodai, OD, Alcon; Laurie Taddonio, LMT Consulting

This session will provide an update to the “how-to” with regard to the process of opening an IDE. During 2011, FDA issued several guidance documents related to IDE, including a FIH (first in human) guidance. The Agency’s expectations and deliverables for pre-submission meetings have also been modified. A review of these modifications will be provid-ed, and their impact will be discussed, along with the optimal approach to opening an IDE in the current regulatory environment. The session will also include an update on how IRBs practices are evolving.

SCHEDULEDevices and IVD Breakout Sessions

Thursday, June 7, 2012


June 6-7, 2012



About OCRAPage 2






Drugs/Biologics/OTC/Generics





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10:30 am - Noon Session #1: Hot Topics and Drugs and BiologicsModerator: Amy GonzalesSpeakers: Dr. Raymond W. Brullo, DPM, Compliance Officer, FDA Los Angeles District Lorna Speid, PhD, RAC, President, Speid & Associates

This session will cover topics of current interest such as developments in the areas of compliance and biosimilars.

Noon - 1:15 pm Lunch with OCRA Member Awards

1:15 - 2:45 pm Session #2: Quality by Design – When It Isn’t Optional, Part 1Moderator: Cindy Fisher, PhD, RACSpeaker: Alex Viehmann, Office of Pharmaceutical Sciences Center for Drug Evaluation and Research (CDER), FDA

This session will discuss efforts at FDA to develop standards for ensuring product quality through QbD approaches. It will also cover implementation of QbD in the real world.

2:45 pm Break

3:00 - 4:15 pm Session #3: Quality by Design – When It Isn’t Optional, Part 2Moderator: Cindy Fisher, PhD, RACSpeaker: Ali Afnan, PhD, President, Step Change Pharma, Inc.

This session will cover process mapping, risk assessment, and tools that can help to develop a QbD approach to manufacturing processes and will summarize QbD and where it’s going.

4:15 - 5:00 pm End of Day Open Panel Discussion With All Speakers from Both DaysModerator: Eri Hirumi, RAC

SCHEDULEDrugs, Biologics, OTC and Generics Breakout Sessions



June 6-7, 2012



About OCRAPage 2







Dietary Supplements




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10:30 am - Noon Session #1: FDA Update on Dietary Supplement Industry Current Hot Topics and Issues You Need To KnowModerator: Vicki WhitsittSpeakers: Daniel Fabricant, PhD, Director, Division of Dietary Supplement Programs, CFSAN, FDA Cara Welch, PhD, VP Scientific/RA, Natural Products Association

Hear from Dr. Fabricant, the Director of FDA’s Dietary Supplement Pro-grams, about the current focus of his office, top priorities and hot topics, including an update on FDMA initiatives. He will also discuss the draft NDI guidance, import issues, product claims and recent enforcement ac-tions including warning letters, product seizures, and criminal cases. Dr. Welch will present an industry insider’s perspective on these issues and present an update on Federal and State legislative challenges.

Noon - 1:15 pm Lunch with OCRA Member Awards

1:15 - 2:45 pm Session #2: Update on FDA GMPs for Dietary SupplementsModerator: Vicki WhitsittSpeakers: Bradford Williams, Manager, Division of Dietary Supplement Programs, CFSAN, FDA Cindy Beehner, President, QSD Consulting

This session will provide an update on the current affairs as they relate to dietary supplement GMPs with focus on the top areas of non-com-pliance, and what industry can do to address the gaps in GMP compli-ance. Mr. Williams will provide an update on FDA GMP priorities (both current and future) and recent inspection findings. Ms. Beehner will discuss compliance issues from an industry perspective and provide insight on how to close these gaps in compliance as well as how to ad-dress FDA 483 observations to avoid FDA warning letters.

2:45 pm Break

3:00 - 4:15 pm Session #3: QA/QC Issues for Dietary Supplement IndustryModerator: Cara WelchSpeakers: Carl Reynolds, Sr. Advisor, Division of Dietary Supplement Programs, CFSAN, FDA Frank Jaksch, Jr., Chief Scientific Officer, ChromaDex

Join a frank discussion of the issues surrounding quality control and quality assurance, including verification testing and laboratory issues. Mr. Reynolds will focus on FDA expectations related to quality functions and setting and verifying appropriate ingredient and finished product specifications for quality and contaminants. Mr. Jaksch will address in-dustry challenges in determining what are appropriate specifications for your ingredients and finished products, conducting verification testing, ensuring verification testing is being performed under GMP-compliant conditions (whether using internal or contract laboratories), and tips on how to work with, qualify and monitor contract laboratories.

SCHEDULEDietary Supplements Breakout Sessions



June 6-7, 2012



About OCRAPage 2











REGISTRATION FORMPage 1 of 3

(please supply all 3 pages)

Please register online for an immediate receipt and confirmation:www.ocra-dg.org

If you prefer to use this form to register, please fax it with your credit card payment to:(949) 266-8461. See next page for paying by check.

NAME of REGISTRANT: Submit one copy for each person attending. Registration Fee includes the following: Access to available speaker presentations to download prior to the conference, CD with speaker presentations after the conference, breakfast, lunch, breaks and parking.

Please check type of card:

______VISA ______ MASTERCARD ______ AMERICAN EXPRESS

Card #: Exp 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.

REGISTRATION RATE

_______$ 725 – 2012 OCRA MembersNote: All OCRA Memberships expired on 12-31-11. If you have not renewed for 2012, please regis-ter at the non member rate to include your membership payment.

_______$ 775 - Non-members (Non Member Rate Includes 2012 OCRA membership)

_______$ 475 – FDA/Government/Students** Student Rate is for individuals enrolled full time in a Regulatory or Quality related academic program at an accredited institution. The Student Rate does not apply to working professionals taking one or two courses on the side. Student ID and copy of current class schedule are required to register at this rate. Final eligibility determined by OCRA.

ONE DAY RATE: _______Wed, June 6 _______Thurs, June 7 _______$ 425 – OCRA Members

_______$ 475 - Non-members (includes 2012 OCRA membership)

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To Register With Company or Personal Check: Please complete the registration form and fax it to (949) 266-8461. If paying by check, please make your check payable to: “OCRA” and mail to 5319 University Dr., Suite 641, Irvine, CA 92612. OCRA’s non-profit Federal Tax ID:# 33-06304553. Only paid attend-ees 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. Phone: (949) 387-9046.

Receipts for Payment: By using the On-Line Registration or PayPal option, you will receive an automatic receipt.

Parking Validation, Name badges and any Conference Materials will be provided at the on-site registration desk.

Cancellations: Cancellations must be received in writing (via email to: [email protected] or via fax) by May 21, 2012. After May 21, if you have reserved a space but do not attend, your payment MUST be remitted (due to our commitment with the hotel). However, an alternate person may attend in your place (non-member replacements will be required to become members for an additional $50 fee.)

Please Provide Complete Contact Information for Each Attendee:(If your address is not provided, we will not be able to mail you the CD of presentations after the conference.)

FIRST NAME: ____________________________________________________________

LAST NAME: ____________________________________________________________

COMPANY: ______________________________________________________________

TITLE: __________________________________________________________________

ADDRESS: ______________________________________________________________

MAIL CODE: _____________________________________________________________

CITY: ___________________________________________________________________

STATE: __________________________________________________________________

ZIP: ____________________________________________________________________

PHONE: ________________________________________________________________

FAX: ___________________________________________________________________

E-MAIL: ________________________________________________________________

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NAME of REGISTRANT: ___________________________________________________

______I Plan To Stay for Lunch on Day 1

______I Plan To Stay for Member Appreciation Reception End of Day 1All attendees are invited for an after-conference reception free of charge on June 6 from 5:15 – 8:00pm

______I Plan To Stay for Lunch on Day 2

______Vegetarian Meal Requested

SELECT THURSDAY BREAKOUT SESSIONSPlease select one for each breakout. Note: To assist with assuring adequate space in each breakout session, please make your selections below. Your selections do not need to be in the same category. Should you decide to change your selection, you can do so on the day of the conference.

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Session Medical Devices Drugs/Biologics DietaryNumber and IVDs OTC/Generics Supplements

1

2

3

Gift Bag Giveaways and Sponsorships AvailableContact Kimberly Syre at [email protected] to inquire about sponsorship opportunities.


June 6-7, 2012



About OCRAPage 2









Driving Directions andHotel Information


Driving Directions and

Sleeping Room Reservations:Irvine Marriott

18000 Von Karman AvenueIrvine, CA 92612

(949) 553-0100HOTEL RESERVATIONS, PLEASE CALL - (800) 228-9290OCRA has a block of rooms at the Irvine Marriott from June 4 through June 7 at the rate of $175.00 for Single or Double Occupancy (is available until May 30, 2012). Please ask for the “OCRA Group Rate”. Online reservations can be made using the link below:

http://www.marriott.com/hotels/travel/laxir-irvine-marriott/?toDate=06/08/12&groupCode=fdafdaa&fromDate=06/04/12&app=resvlink

Shuttle Service:There is shuttle service from the Orange County airport to the hotel. The shuttle runs every 30 minutes outside of Baggage Claim. For faster service it is recommended that you call the Irvine Marriott from the courtesy phone in baggage claim to let them know you are there and waiting.

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 LAX - Los Angeles International Airport:Take 405 South (San Diego Freeway). Exit Jamboree and turn Right off ramp. Turn Right onto Michel-son 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.

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June 6-7, 2012



About OCRAPage 2










List of Acronyms UsedIn this Document

Acronyms Used In This Document

CBER - Center for Biologics Evaluation and Research

CDRH - Center for Devices and Radiological Health

CFSAN - Center for Food Safety and Applied Nutrition

EU - European Union

FDA - U.S. Food and Drug Administration

FDMA - Food and Drug Administration Modernization Act

FIH - First in Human

GMPs - Good Manufacturing Practices

ICH - International Conference on Harmonization

IDE - Investigational Device Exemption

IRB - International Review Board

ISO - International Standards Organization

IVD - In Vitro Diagnostic

IVDD - In Vitro Diagnostic Device

LEED - Leadership in Energy and Environmental Design

LEED AP - Leadership in Energy and Environmental Design Accredited Professional

MDD - Medical Devices Directive

MSDS - Material Safety Data Sheet

NDI - New Dietary Ingredient

OCRA - Orange County Regulatory Affairs Discussion Group

OIVD - Office of In Vitro Diagnostic Device Evaluation and Safety

OTC - Over the Counter

QA - Quality Assurance

QbD - Quality by Design

RA - Regulatory Affairs

RAC - Regulatory Affairs Certification

REACH - Registration, Evaluation, Authorization and Restriction of CHemical

RoHS - Restriction on the use of certain Hazardous Substances

TPLC - Total Product Life Cycle

UN - United Nations

WEEE - Waste Electrical and Electronic Equipment

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the 15th annual fda-ocra educational conference sustainable

Documents