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2014 October Theme: Food Safety and Effectively Transform Organizations
10/9/14 (Thursday) Event Title: "FDA Food Safety Modernization Act (FSMA): The Vision and the Challenge of Improving Food Safety"
10/23/14 (Thursday) Event Theme: "Transforming Organizations: Changing the Work Culture"
To register our 10/23/14 evening event
YOUR FEEDBACKS are important to help with the continuous improvement efforts to our SIG operation, topics, speakers, and events.
To provide your feedback to our Section Chairs: Please email directly to and .
To provide your feedback to our Biomed/Biotech SIG Chair: Please email directly to .
We celebrated our 100th SIG Discussion on 6/5/13.
11/6/14 (Thursday) Event Theme: "Diversity and Inclusion in the Private Sector" (TBA)
11/20/14 (Thursday) Event Theme: "ICH - The Science, Achievements, Impacts, and Challenges for Global Drug Development and Marketing Approval" (TBA)
12/4/14 (Thursday) Event Theme: "Neurological Drug Development and Review - Achievements and Challenges" (TBA)
12/11/14 (Thursday) Event Topic: Scientist-Entrepreneur Series III - "The SKM Citizen-Scientist Tool Set: A New Purely-Mathematical Language for Inspiring World-Class Scientific True-States Assessment Skills in American STEM Students" (TBA)
1/8/15 (Thursday) Event Topic: "Detecting of Emerging and Novel Antimicrobial Resistance - How Whole Genome Sequencing Will Help." (TBA)
2/12/15 (Thursday) Event Theme: "Introduction to and Evolution of Clinical Trial Designs" (TBA)
2/26/15 (Thursday) Event Theme: "Medical Countermeasure and Animal Rules" (TBA)
3/12/15 (Thursday) Event Theme: "Research and Education on Infectious Diseases - Achievements and Challenges" (TBA)
5/7/15 (Thursday) Event Theme: "Advancements and Challenges for Inhalation Therapeutics" (TBA)
Our Upcoming Meeting
Our Past Events, Speakers, and Some Presentations:
Our SIG Mission
The mission of our Biomed/Biotech SIG of ASQ509 is to provide an open discussion and networking platform among regulatory, industry, and academic communities to facilitate truthful and honest, informed quality understanding and practices of biomedical and biotechnological research, operation, services, products, policies, and regulations. Our SIG event topics have been focused on quality principles and practices to facilitate professional advancement, intellectual development, performance excellency, and organizational and personal growth for our members and interested individuals/groups within our local communities while promoting effective and efficient public health services and protect public health.
Our Topic Areas
To provide an open platform to discuss critically the quality principles and practices in conducting scientific research, applying biotechnology, developing biomedical products or services to ensure community sustainability while promote the health of the general public, human and other animals alike.
To promote true understanding and practices in Quality Control, Quality Assurance, Continuous Improvement, Performance Excellency, and growth sustainability.
To facilitate inter-generation, inter-sector, inter-disciplinary, inter-cultural networking and collaboration while building quality operational teams to prepare for any upcoming global challenges.
To model best practices in all aspects of SIG operations for community.
Our Leadership Biographies
Dr. C.J. George Chang (; 240-793-8425 (cell))
Dr. Chang is a native from Taiwan, the Republic of China (ROC), and is a veterinarian, veterinary pathologist, veterinary pharmacologist, and toxicologist by training, and a self-trained bioanalytical chemist.
From 2008-2012, Dr. Chang served as a regulatory biologist (safety reviewer) at the Division of Animal Feeds, Office of Surveillance and Compliance, Center for Veterinary Medicine (CVM), US Food and Drug Administration (FDA). He and his colleagues were responsible to regulate and review the safety of new animal-feed ingredients and assesses the health hazard of incidences of adulteration and/or misbranded animal feed products in the US. In June 2012, he joined the oncology drug review team of the Center for Drug Evaluation and Research (CDER) of FDA as a senior pharmacologist assisting premarket, nonclinical safety/efficacy review for candidate cancer drugs.
Before joining the Federal government in 2008, Dr. Chang had directed the development of biomedical products in biopharmaceutical industry, interacted with FDA and stakeholder organizations for IND submissions, and launched clinical trials; assisted in building a world-known toxicogenomics database in bioinformatic industry to predict candidate drug safety; and managed contract research projects/programs and directed non-clinical safety studies within contract research industry.
Dr. Chang earned his veterinary medicine degree from the National Taiwan University (NTU, Taiwan, ROC), his first MS in veterinary pathology on pathogenesis and animal disease diagnosis from University of Minnesota (St. Paul, MN), and his second MS and his PhD degrees in veterinary physiology/pharmacology on reproductive endocrinology, chemical carcinogenesis, and chemotherapy and chemoprevention for human cancers from The Ohio State University (Columbus, OH). He spent three years afterward conducting postdoctoral research with focus on molecular dosimetry of high impact carcinogens, quantified critical molecular biomarkers, and assessed chemo-preventive potential of candidate drugs for tobacco-specific nitrosamine-induced toxicities in animal models at a Wake Forest University/RJR Tobacco joined postdoc training program (Leon Goldberg Fellowship; Winston-Salem, NC).
Dr. Chang's career goals are to assess the efficacy/utility and safety of candidate biomedical products, to facilitate collaboration within scientific community, and to provide pertinent information protecting and promoting the health of general public. He is board-certified as a general toxicologist (DABT), quality auditor (CQA), regulatory affairs specialist (RAC), and project management profession (PMP).