|
Carol DeSain
Carol DeSain's consulting services focus on regulatory
compliance for biologic, biotech, pharmaceutical, diagnostic,
and combination products. She has worked in the industry for
more than 25 years, with start-ups, global corporations, contract
manufacturers, and allied industries in the U.S. and Europe.
Carol helps her clients with CTD and DMF submissions, establishing new GMP/QSR systems, re-working failing
systems, establishing policy for global corporations and training
management and staff. She is known for her broad knowledge of
the industry, a practical, hands-on approach to compliance,
interactive and informative training sessions, and for the books
she has co-authored on documentation, risk management, validation
and product development.
Prior to consulting Carol worked in basic research (biochemistry,
enzymology, and genetics), product/process development, and
aseptic pharmaceutical manufacturing.
Carol's practice focuses on combination products, sterile pharmaceutical
products, and active pharmaceutical ingredients.
Click here to view Ms. DeSain's CV.
|