Andrea Chamblee

Liaison @Afs Intercultural Programs

Silver Spring, MD, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jan 1991 — Present

Liaison @Afs Intercultural Programs

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Washington, DC, US

Volunteer State Department liaison and mediator for foreign exchange students and their families.

EDUCATION

1983 — 1986

University of Maryland Francis King Carey School of Law

JD, health, administrative law, Food and Drug law

N/A

University of Maryland

BS with honors, Communication, Journalism, and Related Programs; Government and Politics

SKILLS

Corrective and Preventive Action (Capa)21 Cfr Part 11RegulationsU.s. Title 21 Cfr Part 11 RegulationCROGood Clinical Practice (Gcp)Medical DevicesClinical ResearchCapaClinical DevelopmentQuality SystemInfectious DiseasesStandard Operating Procedure (Sop)ComplianceHealthcareStrategyRegulatory AffairsLifesciencesBiotechnologyDrug DevelopmentCRO ManagementGcpBiopharmaceuticalsValidationScienceClinical TrialsBiochemistryMicrobiologyIso 13485ImmunologyCross-Functional Team LeadershipPublic PolicyCtmsGmpLife SciencesPharmaceutical IndustrySopFdaQuality ManagementU.s. Food and Drug Administration (Fda)

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.

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