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Biomed/Biotech SIG: GXP and QA  

Where
Kelly's Deli Conference Center
Next to the entrance to 7519 Standish Drive
FDA/CVM Center
Rockville, Maryland  20855

When
Aug 24    6:00 pm - 8:45 pm (GMT -5:00) EST

“A Biopharmaceutical Industry Scientist’s Journey 
To GXP and Quality Assurance World”
 
To be presented by

Xuejuan Julie Zhang, MS
Quality Assurance Professional

       Thursday, August 24, 2017

6:00 – 6:20 PM – Networking; Pizza/drink 
6:20 – 8:45 PM – Program 
8:45 – 8:55 PM – Door-prizes drawing; Networking
Online Registration site: https://asq509.org/ht/d/DoSurvey/i/35817
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, current job-seekers, Tai-Chi classes students in Metropolitan DC.

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

Registration Deadline: Please register by Thursday noon, August 24, 2017.  

Question: Please contact Dr. C.J. George Chang, Chair of Biomed/Biotech SIG, ASQ509; [email protected] 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 
Our speaker will share the importance of GLP, GCP and cGMP compliance in drug development. As was once the single quality point of contact at a pharmaceutical site, she wishes to lead audience to explore the importance of quality assurance for any organization.  

Audience will also be learning the important functional areas in quality assurance profession, such as quality management system (QMS), site quality plan, audit readiness preparation, deviation & corrective action/prevent action (CAPA) management, cGMP product Batch record review, approval, research study project support, and Food Safety Modernization Act, 21CFR507 compliance preparation process. Our speaker will also clarify/lead discussion for some easy-to-mix terminologies such as QA vs. QC, validation vs. qualification, audit vs. inspection etc.

Speaker’s Bio
Ms. Xuejuan Julie Zhang started her career in Biopharmaceutical sector as a mid-level research associate in the Molecular biology, Gene Discovery, and Antibody Department of Human Genome Sciences Inc. (HGSI). This opportunity enabled her mastering laboratory skills with exposure to how pharmaceutical industry fills drug discovery pipelines. 

After Teva acquihired CoGenesys (R&D core of HGSI) in 2006, Julie grew into an experienced scientist with increasing responsibilities, and served in the Global Bioassay and Technology department operational team. She had been the integral asset for the assay development, method validation, preclinical and clinical sample analysis, automation set-up, GLP compliance assurance and hosted the lunch & learn employee club. 

Julie was later exposed to cGMP-compliant Quality Control while working as Sr. Biologist for cell potency assay testing for GSK Rockville manufacturing site.  Embraced the opportunity into the Quality Assurance arena, Julie was reached out by Eli Lilly for the position to oversee all Quality activities in its Elanco Gaithersburg site. After the Elanco Gaithersburg site was dissolved in the mid-June of 2017, Julie kept her compassion in biopharmaceutical QA, while seeking exciting opportunities supporting drug development. Julie has been actively enriching her knowledge through daily self-learning of drug and food regulations. 

Julie came from Sichuan province of P.R. China and received her B.S. degree in chemistry (major) and biology (minor) from Eastern Nazarene College, MA, and her M.S. degree in Chemistry from University of Maryland, College Park. She is a volunteer in the Chinese Biopharmaceutical Association (CBA) bi-monthly workshop organizing committee.   

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