Biomed/Biotech Special Interest Group  

6:00 – 6:20 PM – Networking; Pizza/drink 

6:20 – 8:45 PM – Program 

8:45 – 9:00 PM – Door-prizes drawing; Networking

$5: non-ASQ members to cover pizza/drink cost; 

Free: ASQ members, veterans, senior citizens, past speakers, teachers, students, interns, residents, postdocs, FDA Commissioner’s Fellows, MJ-DC members, NTUAADC members, CAPA members, CKUAADC members, CCACC volunteers/employees, FAPAC members, CBA members, AAGEN members, Commissioned Corp officers, and current job-seekers. 

Location: Kelly’s Deli Conference Center, 7519 Standish Place, Rockville (Derwood, for GPS users), MD 20855

Registration Deadline: Please register by Thursday noon, October 23, 2014.  

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  

Research has shown that organizational performance and work culture are highly correlated.  Often, attempts to transform the workplace into a high performance organization (HPO) fail because the underlying culture remains static.  This is especially true for large, entrenched organizations like the FDA. 

Changing the work culture can be a daunting task for management.  Many, if not most, attempts are unsuccessful or even counterproductive.  Top down culture change initiatives are especially prone to failure because upper management cannot relate well to the lives of the front line workers, and the information flow is highly filtered as it travels upward in the organization.  Management tends to view the work culture as a monolithic entity when in fact there are multiple different cultures operating within the organization, some vibrant and engaged, others pulling the organization down.  Change initiatives should focus on reducing the toxic cultures without harming the healthy ones.

This presentation will examine certain organizational theories and suggest specific actions management can take to enhance the culture of their organization.

Dr. Stephen Sundlof is the Senior Vice President for Regulatory Affairs at Kindred Biosciences, Inc., a biopharmaceutical company dedicated to bringing the very best science and medicine to companion animals. From 2008 to 2010 he served as Director of the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) which is responsible for ensuring the composition, quality, safety, and labeling of foods, food and color additives, dietary supplements, and cosmetics.  In the 14 years preceding this appointment, Dr. Sundlof served as Director of FDA’s Center for Veterinary Medicine (CVM) which is responsible for ensuring the safety and effectiveness of animal drugs, and the safety of animal feed including pet food.  Prior to joining the FDA, he was a professor at the University of Florida, College of Veterinary Medicine. 

From 1994-2008 he served as chairman of the World Health Organization/Food and Agriculture Organization (WHO/FAO) of the United Nations Codex Alimentarius (Codex) Committee on Residues of Veterinary Drugs in Foods, and is past president of the American Academy of Veterinary Pharmacology and Therapeutics (AAVPT).  He received both his Doctorate in Veterinary Medicine and PhD in toxicology from the University of Illinois, and is a diplomate of the American Board of Veterinary Toxicology (ABVT).