Eliane K. Quinn, M.S.
Principal, Quinn Consulting Services
Eliane is a senior-level consultant
to the pharmaceutical industry with extensive experience in
international CGMP compliance audits, establishment of US-compliant
quality systems, Regulatory Affairs, and communications with
regulatory health agencies.
Eliane has over 18 years experience in
Regulatory Review, with specialized expertise in NDA submissions,
ANDA submissions and compliance. Eliane is responsible for
Compliance issues for meister.NET drug related Web and multi-media
projects.
Prior to establishing Quinn
Consulting Services, Eliane has held several key Pharmaceutical
positions including Director of Regulatory Affairs for Schein
Pharmaceuticals (Sterile product division). Under Eliane's
direction, the company received FDA approval of over 60 NDAs, ANDAs
and AADAs. She also developed the company's Scientific
Information Center.
In the beginning of her career,
Eliane was a Project Leader Microbiologist where she planned and
designed the development of novel cycles of sterilization for
pharmaceutical products and medical devices.
EDUCATION
Montana State University, Bozeman, Montana
Master of Science in Zoology, 1980
Subjects: Genetics, Microbiology
Western Montana College, Dillon, Montana
Bachelor of Science Summa Cum Laude, 1978
Subjects: Biology, Physical Sciences (Physic & Chemistry), French
PRESENTATIONS
DIA - 1999 Annual Meeting
Success Factors in Generic Applications June 27- July 1, 1999
RAPS - Drugs and Devices 1991, Washington D.C.
Generic Drug Approval Process November 7-8, 1991
DEA/Industry Conference: Anabolic Steroid Control Act of 1990, San
Francisco, CA - Industry Perspective April 1, 1991
RAPS - 14th Annual Meeting, Washington D.C.
The New ANDA Approval Process October 15-17, 1990
RAPS - Drug Submission Seminar, Washington D.C.
ANDAs January 22-23, 1990
RAPS - ANDA tutorial, Washington D.C.
Reading and Using the Orange Book July 11-12, 1989
PUBLICATION
A Step by Step Approach to the
Preparation of ANDA's
REGULATORY AFFAIRS, Volume 1, Spring 1989.
PROFESSIONAL AFFILIATIONS
Parenteral Drug Association (PDA)
Drug Information Association (DIA)
