Problem Solver
Jeff Morgan
Areas Jeff Morgan is Knowledgeable in:
Microbiology, FDA Regulations, IVD development
Techniques Jeff Morgan Uses:
Researching the problem (library, internet, scientific journals, regulatory web sites)
Delphi Polls
Design of Experiments Approaches
"Owning" the problem
Delphi Polls
Design of Experiments Approaches
"Owning" the problem
Jeff Morgan's Problem Solving Skills:
- Clinical Microbiology expertise, FDA 21 CFR 820 and ISO 13485
Jeff Morgan's Problem Solving Experience:
- - I have developed immunoassays for biotech and drug companies; some of which have been FDA approved and are currently marketed.
- I have successfully assisted companies with FDA 483 and Warning Letter remediation
- I have assessed in-vitro diagnostic manufacturing methods; my suggestions for improvement reduced scrap rate by 20%.
- I have participated in Value Engineering studies for college science facilities resulting in significant savings.
- I have consulted in areas of regulatory compliance for device and pharmaceutical companies.
- I have developed several rapid microbiological assays.