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2017 April Theme: Open the Secret Neural Networks

5/18/17 (Thursday) Event Topic: "C2016 ICH E6(R2) Good Clinical Practice Amendment - Impact on Quality and CRO Operations"

To Register for Our 5/18/17 SIG Event  


YOUR FEEDBACKS are important to help with the continuous improvement efforts to our SIG operation, topics, speakers, and events.

If you wish to be on our SIG-event-announcement distribution list: Please email your request to C.J. George Chang at gchang2008@yahoo.com or send text to 240-793-8425.

To provide your feedback to our Section Chairs: Please email directly to chair@asq509.org and chair-elect@asq.org.

To provide your feedback to our Biomed/Biotech SIG Chair: Please email directly to biomedtechsig@asq509.org.


We celebrated:

Our 175th SIG event on 7/7/16, 

Our 150th SIG event and the 7th anniversary of our SIG on 6/18/15; and 

Our 100th SIG event on 6/5/13 

(Cake contributor: Mr. Arvinder Singh; photo contributor: Ms. Xiting Yang).

2017 Theme: "The 21st Century Cures Act" - Upcoming Events 

June: Environmental Protection: Clinical Trial Management 

June: Risk Communication; Medical Device regulatory review

July: Consulting Business; Bioequivalence Determination


Our Upcoming Meeting

“2016 ICH E6(R2) Good Clinical Practice Addendum
- Impact on Quality and Clinical CRO Operations” 
 
         To be presented by

Jan Peterson, MS
Senior Regulatory Affairs Manager
Emmes Corporation, Rockville, MD

       Thursday, May 18, 2017

6:00 – 6:20 PM – Networking; Pizza/drink 
6:20 – 8:45 PM – Program 
8:45 – 8:55 PM – Door-prizes drawing; Networking

Open to Public – 
$5: non-ASQ members to cover pizza/drink cost; 
Free: ASQ members, veterans, senior citizens, past speakers, US PHS Commissioned Corp officers, teachers, students, interns, residents, postdocs, FDA Commissioner’s Fellows, MJ-DC members, NTUAADC members, CAPA members, NTMUADC members, CKUAADC members, NTHUAADC members, NJTUAADC members, CCACC volunteers/employees, FAPAC members, CBA members, AAGEN members, NCARSQA members, OCA-DC members, AAMB members, ACAP members, DC Leaders Club members, BioTrain volunteers, and current job-seekers

Location: Kelly’s Deli Conference Center, 7529 Standish Place, Rockville (Derwood, for GPS users), MD 20855

Registration Deadline: Please register by Thursday noon, May 18, 2017.  

Question: Please contact Dr. C.J. George Chang, Chair of Biomed/Biotech SIG, ASQ509; gchang2008@yahoo.com or 240-793-8425 (cell).

Driving directions: By Cars: From I-270 (N or S bound): Take Exit 9A and exit from the FIRST right exit; turn left (east) onto Shady Grove Dr.; turn right (south) onto Rockville Pike (Route 355); turn left (east) onto East Gude Dr.; turn left (north) immediately onto Crabb’s Branch Dr.; turn left (west) immediately onto Standish Place. The first building on your right side is 7519 Standish Place; open parking). The venue is on the first floor of 7529 Building with its external entrance opposite to the left side of 7519 building main entrance. By Metro trains: Off from Red Line Shady Grove Station, and take RideOn Route 59 TOWARD ROCKVILLE and get off from “Calhoun Place” stop. Standish Place is next to the Bus stop. Our venue is within 2 min of walking distance from the stop.

Summary 
Good Clinical Practice (GCP)—and we must read this as “Good Clinical Research Practice” — and quality in clinical research were always expected to go hand in hand. But until the recent update to the 20-year-old international GCP Guidelines, which were adopted as “guidance” by FDA in 1996 in lieu of regulations proposed earlier, quality systems approaches and risk-based methodologies were not widely recommended or utilized in either academic- or industry-sponsored clinical trials. The new “E6(R2)” Guideline update changes that, emphasizing both aspects so that many consider this a significant change to the management approach and operational conduct of clinical research. We’ll discuss key changes to the GCP Guideline and the impact they may have on data managers, quality monitors, and auditors for sponsors and the clinical research organizations (CROs) they hire to manage clinical trials.

 Speaker’s Bio: 
Mr. Peterson’s early career was based in academic settings at the University of Minnesota and the University of California at San Francisco, conducting both preclinical and clinical work in neurophysiology and ocular pharmacology research. He completed his MS degree in Pharmacology and Experimental Therapeutics at UCSF, and accumulated extensive experience in basic pharmacology, physiology, and clinical research in settings including neurosurgical treatments for injury and pain, studies involving cardiology, diabetes, urology, immunology, ocular pharmacology, retinal degenerative conditions, and surgical interventions for glaucoma and refractive errors. So while he has always loved working in a variety of clinical and regulated product areas over the past 40+ years (and mastering none, for sure, especially during those years doing device manufacturing SWAT team inspections), he considers clinical vision research as “home base.” He has been a volunteer on industry-FDA standards development committees since 2004, including an American National Standards Institute (ANSI) Z80 committee for ophthalmic medical devices, and has personally directed and monitored multi-national trials for the successful FDA and CE mark approval of ophthalmic laser products for both refractive surgery and glaucoma, and an implanted ocular device for glaucoma.

Mr. Peterson is the Vice-Chair of the Association of Clinical Research Professionals (ACRP) Regulatory Affairs Committee and a contributing Item Writer to the Academy of Clinical Research Professionals Global CCRA and ACRP-Certified Professional Certification Exam committees. He is Regulatory Affairs Certified (RAC-US) by the Regulatory Affairs Professionals Society (RAPS), a Senior Member of the American Society for Quality (ASQ) and an ASQ Certified Biomedical Auditor (CBA). He has prepared or contributed to numerous successful clinical trial applications (CTAs) for INDs and IDEs from the US FDA, Health Canada, and Israel, as well as successful 510(k), PMA, and NDA marketing applications in the United States. 

He has developed strong professional relationships with FDA regulators for drug, biologic, and medical device applications, and participated and presented at client-FDA meetings and FDA Advisory Panel meetings. Since 1999 he has been employed at a CRO called the Emmes Corporation in Rockville, a growing, private CRO with now over 550 people (owned and run by biostatisticians) whose mission is focused on supporting clinical research trials for government, academic and industry sponsors to generate and disseminate quality clinical research information to benefit the public health. Mr. Peterson would love to travel more but mostly flies a desk now helping various projects navigate the regulatory requirements for their clinical trials as a Senior Regulatory Affairs Manager at Emmes. 

This event is cosponsored by NTU Alumni Association DC Chapter (www.ntuaadc.org) and Chinese American Professional Association DC Chapter (www.capadc.org).

Our Past Events, Speakers, and Some Presentations:

Biomed/Biotech SIG was established in July 2008, and Our SIG events were launched since December 2008.  Up to now, we have discussed quality aspects for the following 192 Biomed/Biotech Topics within the Metropolitan DC communities: 

1. Regulations of Genetically Engineered Animals; [Flyer]
2. Challenges in Our Healthcare Systems & Use of Quality Data to Drive Improvements in Patient Care; [Flyer]
3. Shanghai Clinical Research Center Progress, Challenges, and Its Quality Specimen-Procurement Program; [Flyer]
4. Quality by Design in Pharmaceutical Industry; [Flyer]
5. Nano-particles as Drug Delivery Carriers; [Flyer][Presentation
6. Nano-medicine Clinical Applications and Challenges; [Flyer]
7. Regulatory Challenges in Utilizing Biofuel Co-Products As An Animal Feed Ingredient; [Flyer]
8. Technical Challenges in Converting Biomass to Biofuel; [Flyer]
9. Animal Feed Safety System; [Flyer]
10. Food Safety Considerations of Antimicrobial Drugs for use in Food Animals: Two Different Microbiological Approaches; [Flyer]
11. DNA-barcoding Its Science, Development, and Regulatory Applications at FDA; [Flyer]
12. How Aquatic Research Is Helping to Solve Questions about Melamine Toxicity; [Flyer][Presentation]
13. Melamine in Food; [Flyer][Presentation]
14. Bioinformatics, System Biology, and Translational Medicine; [Flyer]
15. A Systemic Framework of Genome Screening Seeking a Predictive Genomic Composite Biomarker for Potential Treatment Individualization; [Flyer]
16. Oncology Biopharmaceuticals and Preclinical Development; [Flyer][Presentation]
17. Working with the FDA to Test A New Vaccine Regulatory Science 101 for Basic Researchers. [Flyer][Presentation]
18. Medicine Errors. Oops! [Flyer]
19. Steps to a Quality CBER Submission; [Flyer][Presentation]
20. Communicate and Motivate for Quality; [Flyer]
21. Take Charge of Your Career Growth and Development; [Flyer]
22. Gene Therapy Dog Models for Humans; [Flyer]
23. Generic Drugs Myths and Truths; [Flyer]
24. Biomedical/Biotechnology Opportunities and Challenges in Taiwan and China; [Flyer]
25. Research and Development of a Hepatitis E Vaccine China Biomed/Biotech Progress Update I; [Flyer]
26. World Intellectual Property War and its Impact on Pharmaceutical Industry in Taiwan and China China Biomed/Biotech Progress Update II; [Flyer]
27. Changing Regulatory Environment in India for Global Clinical Trials, Etc; [Flyer]
28. FDA/CVM Regulation of Bioengineered Feed; [Flyer]
29. Technology Entrepreneurship; [Flyer]
30. Good Clinical Practice (GCP) Concepts for Quality Clinical Trials; [Flyer]
31. Disaster Recovery and the Role of QA; [Flyer][Presentation]
32. Dangerous Documents: Avoiding Land Mines in Your FDA Record and Emails; [Flyer]
33. Liver Cancer-Free National Program; [Flyer]
34. CDCs Disease Detectives Epidemic Intelligence Services; [Flyer]
35. Why Quality by Design A Case Study; [Flyer]
36. Piron Diseases and FDAs Animal Feed Regulations to Prevent the Spread of BSE in the US Cattle Population; [Flyer]
37. Inspection, Compliance, and Quality Implementation of A New BSE Rule; [Flyer]
38. The New NCI NExT Program A Quality Initiative; [Flyer]
39. Retrovirology AIDS and Other Human Diseases Quality Research, Sciences, and Challenges; [Flyer]
40. Nanoparticles as Drug Delivery Vehicles for Molecular Imaging and Chemotherapy applications Science, utility, and Challenges; [Flyer][Presentation]
41. Three Case Studies of Remediation of Hazardous Waste Contaminated Sites; [Flyer]  
42. China Biopharma R&D Experience 2003 to 2010 Achievements and Challenges; [Flyer]
43. Regulatory Sciences; [Flyer]
44. Medical Device Development Underpinning by Quality System; [Flyer]
45. Incorporating Risk Management into Quality System A Key Operation in the American Red Cross; [Flyer]
46. FDA Import Operations and Challenges; [Flyer]
47. Salmonella in Animal Feed FDA Policy and Regulation; [Flyer]
48. Development of Ciprofloxacin Tablets Using the Concept of Quality by Design (QbD); [Flyer]
49. Quality Automation and Controls in Pharmaceutical Manufacturing Facilities; [Flyer]
50. A County in Transition and Its Impact on Health and Human Services; [Flyer]
51. Improving Health Access and health for Vulnerable Montgomery County Residents; [Flyer]
52. Codex Alimentarius and Veterinary Drugs - Ractopamine HCl as An Example; [Flyer]
53. Montgomery County Leadership Network and Bioscience Strategy and Master Plan; [Flyer]
54. How Do We Know That Food Additives Are Safe - Two Case Studies: Aspartame and Melamine; [Flyer]
55. GLP Modernization - An Update; [Flyer]
56. Design, Construction, and Operation of Multi-drug cGMP Facilities; [Flyer]
57. Overview of Biologics Drug Inspections; [Flyer] [Presentation]
58. European Food Safety Authority (EFSA) - Risk Assessment for Decision-Making and Challenges for EU and US; [Flyer]
59. Path to Senior Executive Services (SES); [Flyer][Presentation]
60. USP Verification Program - A unique 3rd Party Certification Program; [Flyer][Presentation]
61. USP Reference Standards Evaluation - From Material to Reference Standard; [Flyer]
62. Savvy Social Security Planning - What Baby Boomers Need to Know to Maximize Retirement Income; [Flyer]
63. Medicare 101; [Flyer]
64. Mutifaceted Food Safety Challenges - What's Next? [Flyer]
65. How are Candidate Food and Feed Ingredients and Animal Drugs Reviewed at FDA to Ensure Safety of Human Food? [Flyer
66. Information Security and Its New Challenges; [Flyer]
67. Nanotechnology and Its Application in Medical Countermeasure Development; [Flyer]
68. Radiation Toxicity and Syndrome; [Flyer][Presentation]
69. Power Networking through Effective Communications; [Flyer]
70. Japan Fukushima Dai-Ichi Accident - One Year Later; [Flyer]
71. Overview of Healthcare Access within the Fairfax and Montgomery Counties; [Flyer]
72. Effective Communication through Accent Reduction and Modification; [Flyer]
73. Clinical Trials; [Flyer]
74. Getting Ahead: Break the Glass Ceiling; [Flyer]
75. Change Management - Driving Successful Changes and Creating a More Agile Organization; [Flyer]
76. Critical Research Supporting Regulatory Decisions and Actions; [Flyer]
77. Investigation of Curious Cloudiness in a Process Intermediate during Manufacturing of Meniningococcal Vaccine. [Flyer]
78. Melamine in Pet Food - How Poisoning Cats and Dogs Changed the FDA; [Flyer] [Presentation]
79. Development of Molecular Diagnostics - An FDA Perspective; [Flyer][Presentation]
80. Making Smart Cuts; [Flyer][Presentation]
81. Regulation of Genetically Engineered (GE) Animals at the US FDA; [Flyer][Presentation]
82. Epidemiology Operations for National Food Safety; [Flyer]
83. Advances in Development of Pneumococcal Vaccines; [Flyer]
84. M&A in the LS Tools and Rx Space - Synergies, Pitfalls, and Learning; [Flyer]
85. Introduction to Nonprofit Organizations - How to Sustain Mission-Focused Operations; [Flyer][Presentation]
86. Strategic Execution: Pick Projects that Pack a Bunch; [Flyer]
87. Design of Experiments: The Primary Tool in Quality-by-Design; [Flyer]
88. From Paycheck to Passion - Jumpstart Your Career; [Flyer]
89. Leadership and Mission for A High Performance Organization; [Flyer][Presentation]
90. Big Ears vs Large Antennae - When US and Japan Work Together; [Flyer][Presentation]
91. FDA's Device Case for Quality; [Flyer]
92. Conversation on New Cancer Drugs - Development, Approval, and Access; [Flyer
93. SBA Contracting Programs and Federal Supports to Small Business Entrepreneurship; [Flyer] [Presentation]
94. FDA Regulatory Policy - How It Is Made and Who Makes It; [Flyer]
95. Evaluation of Benefit and Risk; [Flyer] [Presentation]
96. Building A Competitive Biologics Pipeline Portfolio through Novel Technologies; [Flyer]
97. The Evolution of Nuclear Safety; [Flyer] [Presentation]
98. Asian Community-Building - Vision, Experience, Challenge [Flyer][Presentation]
99. Career Opportunities at FDA - From A Regulatory Scientist Perspective; [Flyer][Presentation]
100. The Role of Clinical Pharmacology in Risk-Assessment for New Drugs; [Flyer][Presentation
101. Opportunities for Scientist-Entrepreneurs in Biotech Start-Ups; [Flyer]
102. "Hook Them at Hello" with Intentional Networking and Memorable Interview Skills; [Flyer]
103. US Export Controls; [Flyer]
104. What Are We Looking For; [Flyer]
105. From Start-Up to IPO; [Flyer]
106. Overview of FDA's Postmarket Drug Safety and Surveillance. [Flyer]
107. Driving Changes and Getting Results for Community Health in Challenging Time - From A Grassroots' Perspective; [Flyer] [Presentation]
108. Generic Drugs - Application and Regulatory Review. [Flyer] [Presentation]
109. Confession of a Lean Six Sigma Master Black Belt; [Flyer] [Presentation]
110. Systematic Pursuit of Performance Excellence; [Flyer] [Presentation]
111. Nonprofit Organizations - Tax-exempt Status, Good Governance, and More; [Flyer][Presentation]
112. Pinpoint the Causes of Cancer Cluster - Challenges and Opportunities; [Flyer] [Presentation]
113. Overview of Asian American Health Initiative (AAHI), Montgomery County's Department Health and Human Services; [Flyer]
114. FDA's Question-Based Review: A Risk-Based Pharmaceutical Quality Assessment Tool; [Flyer] [Presentation]
115. Trademark Protection; [Flyer]
116. Making Effective Speeches - Tips for Toastmasters and Professionals; [Flyer]
117. Challenges and Opportunities in Developing Biologics and cGMP Operations Excellence in China; [Flyer]
118. How to Avoid Common CMC Deficiencies in INDs and NDAs; [Flyer] [Presentation]
119. How to Protect Intellectual Property against Economic Espionage [Flyer]
120. Dengue Disease: Old Disease, New Challenges; [Flyer][Presentation]
121. The Road So Far - My Career in Toxicology; [Flyer]  
122. Enabling Programs and Leadership to Support FDA/CDER's Mission; [Flyer]
123. Particle Beam Therapy: A Complementary Radiotherapy of Photons - From X-Ray to Protons and Heavier Ions; [Flyer] [Presentation]
124. Copyrights. [Flyer]
125. A Dream within A Dream / The Salad Bowl; [Flyer]
126. Herbal Medicine and Plant-Derived Drugs - A Pharmacognosist's Persective; [Flyer][Presentation]
127. Patent Overview and Patent Cooperation Treaty [PCT); [Flyer]
128. Effectively Applying Sequencing Technology for Translational Cancer Research; [Flyer]
129. HACCP - Its Practical Application and Global Implication; [Flyer]
130. Anthropogenic Global Warming - A Hoax or An Inconvenient Truth? [Flyer
131. Impact of Recent US Health Care Legislation on Patient Care and NIH Research Agenda for Substance Abuse Disorders. [Flyer] [Presentation Part 1][Presentation Part 2
132. Corporate Social Responsibility; [Flyer] [Presentation]
133. The Silent World. [Flyer]
134. Nanomedicine: Improving Current Cancer Therapies; [Flyer]
135. Hearing Loss Prevention and Modern Hearing Aids Technology; [Flyer] [Presentation]
136. FDA Food Safety Modernization Act: The Vision and Challenges of Improving Food Safety;[Flyer]
137. Transforming Organizations: Changing the Work Culture. [Flyer] [Presentation]
138. Adaptive Leaders - Trait for Success and D&I (Diversity and Inclusion); [Flyer] [Presentation]
139. Overview of Parkinson's Disease and Neurology Drug Development; [Flyer]
140. New View of US Science and Medical Innovation Potential - From the STEM Students' Perspective; [Flyer] [Presentation][Handout]
141. Overview of NARMS Program and Detection of Emerging/Novel Antimicrobial Resistance;[Flyer][Presentation]
142. Regulations and Specific Clinical Trial Designs; [Flyer] [Presentation]
143. ICH - Its History, Evolution, Achievements, and Challenges; [Flyer][Presentation]
144. Incorporating Quality Oversight in Clinical Trial Management; [Flyer]
145. Conducting Clinical Trials in China - Opportunities and Challenges; [Flyer][Presentation]
146. Scientific Considerations for Establishing Bioequivalence of Generic Drug Products; [Flyer][Presentation]
147. FDA/CDER Regulatory Affairs and Project Management; [Flyer]
148. Winning Clinical Trials - Some Statistic Review Perspectives; [Flyer]
149. FDA Drug Manufacturing Facility Inspections and Current Good Manufacturing Practices;[Flyer][Presentation]
150. Human Resources Impact on You and the Organization; [Flyer][Presentation]
151. Securing and Sharing the Worldwide Public Health Mission - Serving in the First US FDA Office in India; [Flyer][Presentation]
152. Food cGMP Workshop; [Flyer][Presentation]
153. Food HACCP Workshop; [Flyer][Presentation]
154. Building Diversity/Inclusion/Equality Organizations - Achievements and Challenges. [Flyer][Presentation]
155. Challenges in Nonclinical Development of Inhalation Drug Products; [Flyer][Presentation]
156. How Physical Therapy Impacts Everyone; [Flyer]
157. Experience in Entrepreneurship and Impact Scholarship; [Flyer]
158. Preclinical Product Development for Drugs, Biologics, and Medical Devices - A Veterinary Pathologist's Perspective; [Flyer]
159. Be the Leaders You Already Are; [Flyer][Presentation]
160. Merger and Acquisition - The Best Global Practices on IP-Related Transactions; [Flyer]
161. Mobile Health - Opportunities, Achievements, Challenges and Impacts; [Flyer][Presentation]
162. US Postmarket Safety Surveillance - Medical Device Perspective; [Flyer]
163. Introduction to Regulatory Hematology and Oncology; [Flyer][Presentation]
164. Helping Fight Ebola in the Recent Epidemic at West Africa [Flyer][Presentation]
165. Bone Marrow Mesenchymal Stem Cells - Characterization and Therapies [Flyer][Presentation]
166. Role of Clinical Pharmacology in Biologic Drug Development [Flyer][Presentation]
167. Care for the Seriously Ill: Role of Palliative Medicine and Partnership with Primary Care; [Flyer][Presentation]
168. Development of New Technology and Scientific Capability to Rapid/Sensitive Detection of Microbial Agents in Human Grafts and HCT/Ps. [Flyer][Presentation]
169. Global Market Access and Business Development - An MBDA/White House Initiative Perspective [Flyer][Presentation]
170. US National Antimicrobial Resistance Monitoring System - Achievements and Challenges [Flyer][Presentation]
171. A Rx for Sustainable Agile Culture Transformation for a Global Healthcare Corporation [

Our Past Events, Speakers, and Some Presentations: continued

172. The Romantic Disease: Tuberculosis and Launching Clinical Trials in China [Flyer][Presentation];
173. Follow the Money [Flyer][Presentation];
174. Colorful Leadership - Pave the Way for An Authentic, Fulfilling Career [Flyer];
175. Making of A Socially Conscientious Engineer [Flyer][Presentation];
176. An Examination of the Physical-Mental Association - Results from A Representative Sample of the US General Population [Flyer];
177. The HHS Entrepreneurs-In-Residence Program - Where Superheros Gather in Government [Flyer];
178. Overview of FDA's Expedited Programs with A Case Study of immunotherapy for Renal Cell Cancer [Fyer];
180. Rethink the Science of Cancer - An Integrated 21st Century Cancer Research Conversation [Flyer][Presentation 1][Presentation 2];
181. Development of Companion Diagnostics - An FDA Perspective [Flyer][Presentation]
182. Public Health Strategy to Cope with an Aging Society - Taiwan's Experience on a 10-Year Long-Term-Care Plan [Flyer][Presentation]
183. Introduction to Good Laboratory Practice (GxP workshop Co-sponsored with Chinese Biopharmaceutical Association (www.cba-usa.org)) [Presentation]
184. Current Good Manufacturing Practice and Drug Manufacturing Quality (GxP workshop Co-sponsored with Chinese Biopharmaceutical Association (www.cba-usa.org)) [Presentation
185. Navigating through Unconscious Biases: In Our Community and Workplace [Flyer][Presentation]
186. FDA's Case for Quality and Product Quality Metrics - Medical Device Perspective [Flyer][Presentation 1][Presentation 2]
187. My Experiences as An FDA Statistician ("My disciplinary Role" workshop Co-sponsored with Chinese Biopharmaceutical Association (www.cba-usa.org) [Presentation]
188. How the Cancer Moonshot Task Force Is Unleashing the Power of Data to Help to End Cancer [Flyer][Presentation]
189. Functional Imaging with Positron Emission Tomography (PET). [Flyer][Presentation]
190. The Cancer Genome Atlas (TCGA) Project and Precision Medicine [Flyer]
191. How Do Biological Neural Networks Encode, Learn, Memorize, Recall, and Generalize as A Learning Machine [Flyer][Presentation][Publication]. 
192. ICH E6(R2) GCP Amendment - Impacts on Quality and CRO Operations [Flyer][Presentation]

Our Mission and Event Themes

Our Mission:

This Biomed/Biotech SIG was established in the second half in 2008, when global financial crisis with stock market crash occurred, leading to massive unemployment within our local communities at the Metropolitan DC. 

We have wished to use this open learning/discussion platform to connect critical talents and timely local opportunities while ensured folks can continuously receive interesting but low-threshold education programs through this open forum where academia, industry, and government professionals and administrators meet, greet, network, and inspire for better practices and quality understanding.

1. To provide an open and transparent discussion and networking platform among regulatory, industry, and academic communities.

2. To facilitate truthful and honest, informed quality understanding and practices of biomedical and biotechnological research, operation, services, products, policies, and regulations.  

Our Event Themes:

1. Topics on quality principles and practices to facilitate professional advancement, intellectual development, performance excellency, and organizational and personal growth.

2. For our members and interested individuals/groups within our local communities.

3. To promote effective and efficient public health services to protect public health, human and other animals alike.

Our Focus and Passion

1. To promote true understanding and practices in Quality Control, Quality Assurance, Continuous Improvement, Performance Excellence, and Sustainable Growth.

2. To facilitate inter-generation, inter-sector, inter-disciplinary, inter-cultural networking and collaboration while building focused quality teams to prepare for current and upcoming Local and Global Challenges.

3. To continue improving toward model practices for all aspects of SIG operations for our Local and Global Communities.

Our Leadership Biographies

Dr. C.J. George Chang (gchang2008@yahoo.com; 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). 

 

Career Development for Life!

Becoming Winning Team-Players and Leaders in Biomed/Biotech Sectors!

Why and How We Have Successfully Built A Biomed/Biotech SIG?