Debbie Koeneman has been working as a Partner and Expert Consultant at Nda Partners Llc since 2018. Additionally, this person has an employment history at more than four companies in the related field. Debbie has a total work experience of 13+ years. Debbie Koeneman studied at the Arizona State University from 1986 to 1993. Currently this expert lives in Phoenix, Arizona region. You can find this expert's actual email address and number through SoftwareOfficial search.
Name variants:
Deborah Koeneman,
Debra Koeneman
Last updated Apr 30, 2024
Contact Information
Workplace
Colleagues
Work History
Partner and Expert Consultant
40 Commerce Ln SUITE D, Rochelle, VA 22738
from Dec 2018
President
I service pharmaceutical, biotech, combination product and medical device industries in all aspects of FDA regulatory affairs.
from Apr 2006
Senior Director Regulatory Affairs
I was in charge of FDA regulatory affairs for OrthoLogic for both the medical device business and the pharmaceutical business. I primarily provided regulatory strategy and oversight, as well...
1996 — 2006
Scientific Reviewer and Compliance Officer
I worked as a scientific reviewer in CDRH's Office of Device Evaluation for both the Plastic & Reconstructive Surgery Branch and the Orthopedic Devices Branch (back then my maiden name was L...
Oct 1993 — Aug 1996
Education
1986 — 1993
Occupations
Executive
Chairperson
Partner
Counselor
Chief Executive
Advisor
Skills
Fda
Medical Devices
Regulatory Affairs
Clinical Trials
Clinical Development
Biotechnology
Drug Development
Design Control
Regulatory Requirements
Pharmaceutical Industry
Regulatory Submissions
Capa
Validation
Gmp
Iso 13485
Ind
Protocol
Clinical Research
Lifesciences
Quality System
Biomedical Engineering
Pharmaceutics
Pma
V&V
Gcp
Technology Transfer
Cro
Annual Reports
Oncology
21 Cfr Part 11
Biopharmaceuticals
Cmc
Change Control
Glp
Sop
Nda
Ce Marking
Iso 14971
Pharmacovigilance
Fda Gmp
Biomaterials
Gxp
Biologics
Immunology
Combination Products
Bioengineering
Management Review
Sop Development
Ectd
Irb
FAQs about Debbie Koeneman
What is the main profession of Debbie Koeneman?
This professional's job is President
What are the main profession of Debbie Koeneman?
These person's professions are Executive and Chairperson
Where does Debbie Koeneman currently live?
Debbie Koeneman currently lives in Phoenix, Arizona.
Does the professional have the email address?
de**@koeneman.org is Debbie Koeneman's email address.
Where did Debbie Koeneman work?
This person worked at Nda Partners Llc, Koeneman Regulatory Solutions.
Where has Debbie Koeneman studied?
Debbie studied at the Arizona State University from 1986 to 1993.
What is professional industry that Debbie Koeneman is connected to?
Debbie Koeneman works in Pharmaceuticals industry.
What are special skills of Debbie Koeneman?
This person has such skills as Fda, Medical Devices, Regulatory Affairs, Clinical Trials, Clinical Development, Biotechnology, Drug Development, Design Control, and Regulatory Requirements.