The U.S. Food and Drug Administration is offering another opportunity for stem cell clinics to work with the Agency and understand the regulatory framework. Will it work this time around? This blog article recaps how we got to this point...
The U.S. Food and Drug Administration is offering another opportunity for stem cell clinics to work with the Agency and understand the regulatory framework. Will it work this time around? This blog article recaps how we got to this point...
Part of the MaRS Best Practices Series - Pre-Clinical development workshop
http://www.marsdd.com/bestpractices/
Speaker: James Ault, VP Regulatory Affairs, Ricerca BioSciences
1. Damaris Mejia
mejia.damaris.0783@yahoo.com
818-486-1165
8848 Katherine ave
Panorama City CA 91402
Education
September 2009 - June, 2012
California State University Northridge, Northridge, CA.
Post-baccalaureate Degree in Cellular/molecular/physiology/MicroBio
September, 2006 - June, 2009
California State University Northridge, Northridge, CA
Bachelor of Arts Degree, Biology
September, 2004 - June, 2006
Los Angeles Pierce College, Woodland Hills, CA.
General Education certification, AA degree
Medical and Biological Work Research Experience
Cancer Research
-Biotechnology techniques
-Supervisor
-Data entry and analysis
-Inventory
-Proper safety procedures
-Quality control
Cellular/Molecular/Physiology
Research
-Cell/Plant and tissue culture
-Sequencing
-QPCR
-Electrophoresis
-Western Blots
-ELISA
-Transgenes
-Protein isolation
-Purification
-Flow cytometry
Medical Microbiology/Immunology
-Specimen collections
-Gram stains
-Analyzed microbial substances
-Identifying and isolating infectious
disease-causing organisms
-Optical and electron microscopes
-Gas chromatographs
-Aseptic techniques, agar plate
preparation and streaking
-Quantification: Colony Forming Units
(CFU)
-Dilution plating
-Plaque forming units for phage
identification (PFU)
-Bacteria cultivation, isolation and
identification
Cell / Plant and Tissue Culture
-Cell growth culture, preservation and storage
-Maintenance: growth pattern and harvesting
-Monitor media and growth requirements
-Cell counts, freezing cells, thawing frozen cells.
-Aseptic techniques
2. -Plate preparation and inoculation, dilutions, titrations
-Column chromatography
-Slide preparation and recombinant DNA
Clinical Practices
Medical/Administrative
-Medical History (SOAP)/Charting
-Medical Record Review
-Educate and counsel patients about the normal growth, nutrition plans, physical
development and health maintenance
-Clinic procedures:
visual acuity
audiometry
EKGs
flow peaks
spirometer tests
-Insurance companies and pharmacies
-EHR system
-Medical referral
-Prior authorizations
-Pre-ops
-Prepare and schedule Government Medical Audits.
FDA regulatory compliance projects experience
1) Affordable Care Act (ACA)
2) Center for Disease Control and Prevention (CDC)
3) Others: The Health Insurance Portability and Accountability Act (HIPAA),
Department of Health Care Services (DHCS), Family Pact program, Child Health and
Disability Prevention (CHDP).
Quality Control Experience
-Maintain of records, lab notebooks and logbooks.
-Troubleshooting unexpected or unsatisfactory results
-Implemented alternative procedures
-Monitored accuracy of work/data recorded
-Validation of results
-Evaluated and analyzed data obtained
-Supervised the improvement of operating procedures and its efficiency
-Contribution of the manuscripts/publication
-Ensuring safety procedures
-Guidelines in handling and disposal of bio-hazardous
3. Publications/ Presentations/ Awards
Parameters Affecting Cell Binding to Lectin Beads in Carbohydrate-Base Drug
Development. FASEB Journal, Vol 22, abs 465, pgm 8082 (2008)
Languages
English/Spanish
Skills
Computer Skills: Microsoft word,
PowerPoint, Excel, Internet Explorer
and other software and hardware skills.
Office Ally EHR system
Oral/written communication and math
skills
Biometry statistical analysis