Andrea Chamblee
Member, Board of Education for HoCo MD D5. Everytown Fellow, RAPS Fellow; FDLI Leadership Award; 100 Women of the Year MD; Baltimore Sun Women to Watch;WAMU People We Met 2019. Co-author, Capital of Basketball
- Role
- Liaison at Afs Intercultural Programs
- Location
- Silver Spring, MD, US
- LinkedIn followers
- 500 followers
About Andrea Chamblee
I have over 35 years experience as a Food and Drug Attorney. I am a trained FDA investigator, regulations and compliance expert, Agency liaison; and Fellow at RAPS. I am an award-winning editor and writer; mass shooting survivor; EveryTown Gun Safety Fellow; and an elected leader who beat my politically-established, book-banning, anti-LGBT opponent in a landslide. Admitted: MD Bar (1986), DC (1989).Distinguished Service and Leadership Awards (FDLI 2022). RAPS Fellow 2008. Everytown Fellow (2020).RAC certified (RAPS 1993). Effective Communication certified (RAPS 2021). Executive Development Program Graduate 2008, Kellogg School, Northwestern University, 2008.I prepare for, manage, and respond to FDA inspections and regulatory actions. I successfully propel products and solutions for all regulated products: assess, identify, collaborate, implement compliant solutions in resource-limited environments to secure and expand approvals while improving productivity. I identify and deliver solutions on quality, compliance and enforcement. I am experienced with all commodities and issues from concept to commercialization, reimbursement, inspections, and compliance. I am an experienced team leader and motivator, a coach, and mentor.
Experience
Liaison
Jan 1991 — Present · Washington, DC, US
Volunteer State Department liaison and mediator for foreign exchange students and their families.
Education
University of Maryland Francis King Carey School of Law
JD, health, administrative law, Food and Drug law
1983 — 1986
University of Maryland
BS with honors, Communication, Journalism, and Related Programs; Government and Politics
Skills
- Corrective and Preventive Action (Capa)
- 21 Cfr Part 11
- Regulations
- U.s. Title 21 Cfr Part 11 Regulation
- CRO
- Good Clinical Practice (Gcp)
- Medical Devices
- Clinical Research
- Capa
- Clinical Development
- Quality System
- Infectious Diseases
- Standard Operating Procedure (Sop)
- Compliance
- Healthcare
- Strategy
- Regulatory Affairs
- Lifesciences
- Biotechnology
- Drug Development
- CRO Management
- Gcp
- Biopharmaceuticals
- Validation
- Science
- Clinical Trials
- Biochemistry
- Microbiology
- Iso 13485
- Immunology
- Cross-Functional Team Leadership
- Public Policy
- Ctms
- Gmp
- Life Sciences
- Pharmaceutical Industry
- Sop
- Fda
- Quality Management
- U.s. Food and Drug Administration (Fda)
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