Denise Dion Email & Phone Number
Vice President Regulatory and Quality Services @ EduQuest
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Denise Dion Location
- Gaithersburg, MD, US
Denise Dion Work
- Vice President Regulatory and Quality Services @ (January 2011 - Present)
- Investigator @ U.S Food and Drug Administration (February 1985 - November 2002)
- Investigator @ FDA (January 1985 - January 2002)
- Investigator @ Food and Drug Administration (FDA) (January 1985 - January 2002)
Denise Dion Education
- Wayne State University
Aquatic Ecology (Microbial Ecology, Genetics)
1984-1992 - Western Michigan University
BS (Biology)
1979-1983 - Santa Rosa Community College
EMT (Emergency Medicine)
1979-1979 - Community College of the Air Force
Assoc (Emergency Medicine)
1974-1979
Denise Dion Skills
- Quality Systems Auditing and Compliance
- Medical Device Regulations
- Pharmaceutical Regulations
- Biologics Regulations
- FDA Regulatory Training
- Computer System and Software Validation
- Pharmaceutical Industry
- Quality Auditing
- FDA
- 21 CFR Part 11
- Medical Devices
- Regulations
- Compliance
- Validation
- Quality System
- GMP
- Regulatory Affairs
- V&V
- ISO 14971
- ISO 13485
- Clinical Trials
- Design Control
- CAPA
- Biotechnology
- Quality Management
- Risk Management
- PMA
- Change Control
- Computer System Validation
- GxP
- Regulatory Submissions
- Regulatory Requirements
- GLP
- Sop
- Quality Assurance
- LIMS
- FDA GMP
- Aseptic Processing
- IND
- Cleaning Validation
- Technology Transfer
- Sterilization
- CE marking
- Medical Device Directive
- Biologics
- GCP
- Trackwise
- Biopharmaceuticals
- Quality by Design
- ICH guidelines
- Air Force
- Food
- Photoshop
- Strategy
- Administration
- Research
Denise Dion Summary
- Denise Dion, based in Gaithersburg, MD, US, is currently a Vice President Regulatory and Quality Services at EduQuest, Inc.. Denise Dion brings experience from previous roles at U.S Food and Drug Administration, FDA and Food and Drug Administration (FDA). Denise Dion holds a 1984 - 1992 Aquatic Ecology in Microbial Ecology, Genetics @ Wayne State University. With a robust skill set that includes Quality Systems Auditing and Compliance, Medical Device Regulations, Pharmaceutical Regulations, Biologics Regulations, FDA Regulatory Training and more.
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