Joint Networking Event: ASQ, PDA and SoCalBio
Thursday, October 6, 2016 from 4:00 PM to 8:30 PM (PDT), Hilton Irvine/Orange County Airport, 18800 MacArthur Boulevard, Irvine, CA 92612
FDA 483 Trending Topics and Solutions
- Keynote: Dr. Marlene Garcia Swider, FDA Quality System Manager
- Technical Session: FDA 483 Trending Topics and Solutions
- Table-top Exhibits
- Speed Networking
- Western Theme (including Best Cowboy Attire contest)
- Gourmet Buffet, Wine & Beer, Cash Bar
- Raffle Prizes
- transport from San Diego, Los Angeles and Thousand Oaks
Who should attend?
Professionals from the life science, food, drug and cosemetic industries involved with the development, manufacture, testing, quality control and distribution of regulated products.
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
ATTENDEE REGISTRATION includes:
- 1 Attendee Ticket
- 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.
About American Society for Quality
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. Our Mission is to increase member value by conducting activities and involving members to fulfill the Division’s Vision. www.asq.org/fdc
About Parenteral Drug Association (PDA)
PDA is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. PDA’s Mission is to develop scientifically sound, practical technical information and resources to advance science and regulation for the pharmaceutical and biopharmaceutical industry through the expertise of our global membership. http://www.pda.org
About Southern California Biomedical Council
The Southern California Biomedical Council (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
Dr. Michael R. Hamrell is the President of MORIAH Consultants
MORIAH Consultants is 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..
Dr. Marlene Garcia Swider, Quality System Manager LOS-DO, FDA- ASQ
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 served 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.
Barbara Unger, President Unger Consulting
Barbara Unger formed Unger Consulting Inc. in December 2014 to provide GMP Quality consulting services to the pharmaceutical industry. She has extensive expertise in this area having led the Amgen Inc. Corporate GMP audit group that had responsibility for API and drug substance sites, Quality Systems and computers. She also developed, implemented, and maintained the GMP regulatory intelligence program for eight years at Amgen Inc. This included surveillance, analysis, and communication of GMP related legislation, regulations, guidance, and industry compliance enforcement trends. Barbara was the first chairperson of the Rx-360 Monitoring and Reporting work group (2009 to 2014) that summarized and published relevant GMP and supply chain related laws, regulations, and guidance. She also served as the chairperson of the Midwest Discussion Group GMP-Intelligence sub-group from 2010 to 2014. In 2015, Barbara participated in a Validant Inc. program of data integrity / data management assessments for a large international firm.
Before Amgen, Barbara worked for the consulting firm Don Hill and Associates, providing regulatory and quality services to the pharmaceutical industry, and for Eli Lilly and Company in quality and CMC regulatory affairs positions. She began her career in the pharmaceutical / device industry with Hybritech Inc. and received a bachelor’s degree in chemistry from the University of Illinois in Urbana Illinois.
Susan Bain, SRSc, Keck Graduate Institute
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. She holds a graduate certificate in Effective Supervision from Cal Poly Pomona and is a member of the Orange County Regulatory Association (OCRA), DIA, PDA and RAPS.