SoCal PDA Chapter’s 6th Annual Industry Summit Expo

SoCal Bio and ASQ / Food, Drug, Cosmetic Division

PDA is the leading global provider of science, technology and regulatory information and education for the

pharmaceutical and biopharmaceutical community. http://www.pda.org

SoCalBio promotes and supports biomedical and biotechnology research, development, and manufacturing in

the Greater Los Angeles region for economic development and job creation. http://www.socalbio.org

ASQ FD&C's Vision is to be recognized as the resource of choice for quality systems and leadership

development in Food, Drug, and Cosmetic industries. www.asq.org/fdc

Thursday, October 06, 2016 , 4:00pm – 8:30pm

Hilton Irvine / Orange County Airport

- Keynote Speaker: Dr. Marlene Garcia Swider

- Technical Speakers: Barbara Unger & Susan Bain

- Table Top Exhibits

- Western Theme (Best Western Attire Contest)

- Gourmet Buffet, Wine & Beer, & Cash Bar

- Raffle Prizes

- Transport from SD, LA, & Thousand Oaks

Professionals from the life science, drug, and biologics industries involved with quality, manufacturing,

regulatory compliance, and laboratories.

“FDA 483 Trending Topics and Solutions”

Event Program

4:00-4:50 - Registration Open/Exhibits Open/Open Networking/Beer & Wine Tasting/Appetizers

4:50-5:00 - Welcome/Opening Comments

5:00-5:30 – Keynote Speaker: FDA 483 Trending Topics

5:35-5:55 - Technical Session 1: Visual Inspection Execution & Documentation of Defects and

Container/Closure Integrity

6:00-6:20 - Technical Session 2: Data Integrity and Documentation Observations

6:25-6:45 - Panel Discussion/Q&A

6:45-7:00 - Exhibits & Open Networking

7:00-7:30 - Speed Networking

7:30-8:15 - Buffet/Exhibits/Open Networking

8:15-8:30 - Raffle/Closing Comments

Dr. Marlene Garcia Swider,

Quality System Manager

Pharmaceutical industry expert with over 25 years in the industry

including small venture capital start-up, and large pharmaceutical

firms. Expertise in the biotech area and traditional small molecule

drugs, both parenteral and solid oral.

Barb has held leadership roles of increasing responsibility in global

companies such as Amgen and Eli Lilly. At Amgen she developed,

implemented and maintained comprehensive GMP Regulatory

Intelligence program, including surveillance, analysis and

communication of new or revised legislation, regulations, guidance

and GMP inspection trends for major regulatory jurisdictions. She is

a founding chairperson and 5 year leadership of Rx-360 working

group for GMP/GDP Intelligence Reporting and also led GMP

Intelligence subgroup of the Midwest Discussion Group 2010-2014.

Currently she provides quality consulting services to the

Pharmaceutical and biotech industry including GMP auditing and

remediation.

Barbara Unger, President

Keynote Speaker:

Dr. Marlene Garcia Swider has served in the FDA for more than 29

years in different capacities including Public Affairs Specialist

(working with Congressional issues), Biotech Reviewer, Budget and

Planning Analyst, Investigator, and Regulatory Project Manager.

Most recently she serves as the Quality System Manager for Los

Angeles District Office, FDA. She has a Bachelor in Science, a

Masters in Health Services Administration, and a doctorate degree

in Organizational Management. In acting capacity she has also

serves as Special Assistant to the ACRA and Deputy Director for

ORM, FDA, in the past. She resides in Orange County, California

with her husband and 3 children. She loves square dancing, biking,

hiking, gardening, and cooking. She actively volunteers in the

community leading bible studies and coordinating events. She is

also a professional public speaker and published author for different

professional entities including ASQ, AAPS, IVT, OCRA, BioCom,

and BioPharm Journal.

Dr. Michael Hamrell, President

Program Moderator:

Dr. Michael R. Hamrell is the President of MORIAH Consultants, a

Regulatory Affairs/Clinical Research consulting firm located near

Los Angeles, CA. He has worked in drug development, clinical

research and regulatory affairs for over 30 years. He has worked in

pharmaceuticals, contract research, government, and biotech

industries, in domestic and international regulatory affairs and

clinical research. Dr. Hamrell also worked in the Division of AIDS in

NIAID at the National Institutes of Health, and as a reviewer in the

Center for Drug Evaluation & Research at the Food and Drug

Administration (FDA), in the Divisions of Antiviral Drug Products,

Oncology Drug Products, and Bioequivalence..

SoCal PDA Chapter’s 6th Annual Industry Summit Expo

Thursday, October 06, 2016 , 4:00pm – 8:30pm

Hilton Irvine / Orange County Airport

Susan Bain, DRSc. is currently Professor of Practice, Clinical,

Regulatory and Quality; Program Director, MBS in Clinical and

Regulatory Affairs for Keck Graduate Institute’s (KGI) School of

Applied Life Science and Adjunct Professor of Practice and

Concentration Coordinator for Clinical and Regulatory Affairs in

KGI’s School of Pharmacy. She is an accomplished quality and

regulatory professional with experience in the medical device,

pharmaceutical, and biotechnology industries. She has a diverse

regulatory compliance background in a broad range of FDA-

regulated industries. Her most recent corporate experience includes

serving as a Vice President of Quality/Regulatory Assurance and

Operations at a medical device company and has held various

management positions in Quality Control/Assurance and Regulatory

Affairs over the past 25 years with firms including Baxter

Healthcare, Grifols, Medegen, Inc., Peregrine Corporation, and

Watson Pharmaceuticals. Additionally, Susan also worked at the

FDA as an Investigator, focusing on drugs and medical devices.

Susan received a Doctorate of Regulatory Science (DRSc), a

Master of Science in Regulatory Science (MSc) from the University

of Southern California (USC) and a Bachelor of Science in

Biological Science from Cal Poly, Pomona.

Susan Bain, SRSc, Keck

Graduate Institute

- 1 Attendee Ticket

- Parking

- Appetizers, Dinner, Dessert

- Technical Sessions

- Beer & Wine Tasting

- Exhibitor Showcase

- Commemorative Gift

- $10 Round Trip Transportation Available

(From Thousand Oaks, Los Angeles, and San

Diego) *Contact PDA Event Coordinators for

additional details.

EARLY REGISTRATION PRICING EXTENDED!

Members $30.00

Non-Members $40.00

Student / Government $20.00

After 9/30/16

Members $40.00

Non-Members $50.00

Student / Government $25.00

Registration Assistance?

Contact: DeShawn Wynn, deshawn.wynn@wynningtouch.com

•Azbil BioVigilant

•Azzur

•Beckman Coulter

•ClorDiSys Solutions

•Ellab

•EMD Millipore

•Enterey

•Eurofins Lancaster Labs

•Irvine Pharmaceutical Services

•KAYE

•Lonza

•NSF Health Sciences

•Particle Measuring Systems

•Pharma-Bio Serv

•Pharmatek Laboratories, Inc.

•Rescop

•Royal Welding & Fabricating

•Sika Corporation

•SQA Services, Inc.

•Steris Corporation

•Technical Safety Services

•Veltek Associates Inc.

Additional exhibitors to be listed...

- -

SoCal PDA Chapter’s 6th Annual Industry Summit Expo

Thursday, October 06, 2016 , 4:00pm – 8:30pm

Hilton Irvine / Orange County Airport

- 6ft table top exhibit display with Cover & Chair

- One attendee registration w/ Reserved Parking

- Appetizers, Gourmet Buffet Dinner & Dessert

- Beer & Wine Tasting

- Commemorative Gift

- Logo Advertised in Event Material

- Location selection based on order of registration

- Exhibit Materials must be table-top

- Pull-Ups / standees can be used behind the table

- No display items allowed on the walls

- Electricity available at select tables (see floor plan)

- Exhibitor Setup: 2:30-4:00pm

- Logo listed in flyer w/ hyper link to web site in pre & post email

announcements

- Includes 2 additional attendee tickets can be used to invite customers

- Sponsor recognition on event signage

- Sponsor highlighted in event program

- Literature included in sponsor bag

- Sponsorship is recognized during opening remarks

$375.00 -1 Available

$375.00 -1 Available

$300.00 -1 Available •Round-Trip transportation for event attendees

$275.00 -4 Available •Sponsor logo on reusable bag, includes sponsor literature

$275.00 -2 Available

$275.00 -2 Available

$175.00 -2 Available

$175.00 -2 Available

- - SoCal PDA Chapter’s 6th Annual Industry Summit Expo

Floor Plan

Hilton Irvine / Orange County Airport

- - SoCal PDA Chapter’s 6th Annual Industry Summit Expo

Hilton Irvine / Orange County Airport