Leah Db Carter Email & Phone Number

Chicago, Il, Us

Chicago, Il, Us

Special Prosecutions Bureau: Gun Crime Strategies Unit

Chicago, Il

Regulatory WritingRegulatory IntelligenceCurriculum developmentMedical Writing & Editing

Chicago, Illinois, United States

Special Prosecutions: Gun Crimes Strategies Unit

Biological Sciences Division, Internal Medicine

• Develop and implement regulatory compliance programs for portfolio of 10 fellowship and residencies within the Department of Medicine(Hematology / Oncology, Palliative Care, Gastroenterology, Transplant Hepatology, MedPeds, Geriatrics, Nephrology, Infectious Diseases, Sleep, Pulmonary & Critical Care)• Coordinate and oversee all accreditation activities and submissions within portfolio of programs• Liaison with core program and subspecialty program directors to identify and implement improvement strategies• Formulate corrective action plans• Provide faculty and staff guidance plus training for fellows on regulatory and accreditation activities

• Designed and implemented Best Practices, Standard Operating Procedures, and Regulatory compliance program for new department of Veteran’s Affairs• Created and maintained databases covering all aspects of intake, tracking, assessment, and analysis including formulating charts and graphs to clearly depict results, trends, risk probability, and liability• Identify and address patterns of non-compliance with regard to regulations• Training new staff on procedures and compliance issues

• Guided over 170 manufacturers, diaper services, and artisan members through difficult and new legal legislation on children’s product safety (the CPSC’s Children’s Products Safety Improvement Act of 2008) with member wide calls, talks, presentations, and one on one communication • Grew membership of 501(c) by 30% to 170+ members• Researched, drafted, and submitted industry statements regarding proposed legislation• Identified patterns of non-compliance with regard to federal regulations on importing, labeling, and safety• Designed and implemented numerous training webinars to educate and correct improper practices• Wrote numerous responses to CPSC and FTC Call for Comments • Researched, compiled, and submitted reports to the CPSC and the FTC on related industry legislation, testing results, and member compliance • Invited to speak to the Consumer Product Safety Commission on two occasions • Worked closely with the Small Business Ombudsman on language drafting, industry, and small batch concerns • Sourced resources from Georgia Tech’s Enterprise Innovation Institute to develop a custom compliance and tracking system which allows manufacturers of all sizes to comply with record keeping, recall requirements, and all relevant aspects of the CPSIA of 2008. This tracking system has now been distributed to over 3,000 businesses and is currently being implemented in New York state’s Iroquis White Corn Project to aid farmers in meeting FDA regulations.

Carrollton, Ga

• Managed worldwide distribution (import and export) of 5 successful product lines from inception to design, production, and distribution • Hired, managed, and trained more than 12 long term employees • Negotiated product placement in worldwide markets and media • Analyzed and implemented all buying and sourcing strategies including compliance with federal regulations (FTC, import/export, CPSC, FDA)

Doctor Of Law - Jd

Masters Of Science (Ms), Regulatory Affairs: Pharmaceutical, Biomedical, And Health Policy, 3.76

Pharma, Medical Device, Clinical Trial Management, QA/QI, Process Design and Validation, FDA law, Ethics, Interagency Cooperation.

Philosophy Of Law

Philosophy And Ethics

Ba, Philosophy