Leachables and Extractables Handbook (ePub)

DOUGLAS J. BALL is a board-certified toxicologist (Diplomate
of the American Board of Toxicology) and currently employed by
Pfizer Inc. as a Research Fellow in drug safety R&D
specializing in regulatory strategy and compliance. He chairs the
Extractables and Leachables Safety Information Exchange (ELSIE)
Board of Directors, and the Toxicology Team of the Product Quality
Research Institute (PQRI) Leachables and Extractables Working Group
for both OINDP and parenteral and ophthalmic drug products.

DANIEL L. NORWOOD is a Distinguished Research Fellow in
Analytical Development at Boehringer Ingelheim and has more than
thirty-five years of professional experience. He chaired the PQRI
Leachables and Extractables Working Group and is a thirty-two-year
member of the American Chemical Society (ACS). Dr. Norwood is a
member of the ELSIE Board of Directors.

CHERYL L. M. STULTS is a Senior Fellow at Novartis
Pharmaceuticals Corporation, focusing on materials analysis and
characterization. She chairs the International Pharmaceutical
Aerosol Consortium on Regulation and Science (IPAC-RS) Materials
and Leachables and Extractables Working Groups and is a member of
the ELSIE Board of Directors. Dr. Stults is a thirty-three year
member of the ACS.

LEE M. NAGAO is a Senior Science Advisor in the
Pharmaceutical Practice Group at Drinker Biddle & Reath LLP. As
a member of the IPAC-RS Secretariat, Dr. Nagao supports the
Consortium's initiatives in materials quality, leachables and
extractables, supplier quality, and foreign particles. She was a
member of the PQRI OINDP Leachables and Extractables Working Group
and serves as Science Advisor and Secretariat to the ELSIE
Consortium. Dr. Nagao is a member of the ACS and the AAAS.

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