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Mr. Green provides consulting
services in the scientific and regulatory aspects of a wide
range of medical devices and biologics with particular expertise in
the area of quality systems regulations (QSRs) and quality assurance
(QA/QC).
Mr. Green has a BS (Microbiology) from the
University of Sciences in
Philadelphia (formerly the Philadelphia College of Pharmacy and
Science). Mr. Green has over 12 years of industry experience in
manufacturing biotechnology-derived products.
Mr. Green has
participated in both pre and post-approval FDA inspections while
acting as a scientific/technical expert for major biopharmaceutical
companies.
Mr. Green has also participated in numerous “mock” audits
designed to review pharmaceutical manufacturing processes and
technical documents in preparation for FDA inspections.
Mr. Green's background is particularly useful
to clients
with biomedical products where expertise in good manufacturing
practices issues is required.
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