The SoCal PDA Chapter's 6th Annual Industry Summit Expo will take place on October 6, 2016 from 4-8:30 pm at the Hilton Irvine/Orange County Airport. The event will feature keynote speakers, technical sessions, table top exhibits, networking opportunities, and a gourmet buffet. Speakers will discuss FDA 483 trending topics and solutions, visual inspection and documentation, and data integrity observations. The expo is aimed at professionals in the life science, drug, and biologics industries involved in quality, manufacturing, and regulatory compliance.

1. 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

2. 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..

3. 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

4. •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...

5. - -
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

6. - -
SoCal PDA Chapter’s 6th Annual Industry Summit Expo
Floor Plan
Hilton Irvine / Orange County Airport

7. - -
SoCal PDA Chapter’s 6th Annual Industry Summit Expo
Hilton Irvine / Orange County Airport