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Takashi Yamaoka, Associate Consultant, PhoenixSM
representative in Japan, has nearly 40 years in the pharmaceutical
industry and as an independent consultant. He has
extensive experience in pharmaceutical development
laboratories and Quality Assurance. Mr. Yamaoka has
also contributed to premarket submissions (NDAs and
SNDAs) by preparing the CMC documents. He has conducted
PAI and routine audits to meet the USFDA, MCA, Canadian
and German requirements for intermediate drug substances,
drug products including vaccines, various dosage
forms and sterile and non-sterile products. He has
been a consultant for over 30 companies that have
been inspected by the USFDA. He has also delivered
the presentation, “Points for Successful FDA Inspection”
to numerous Japanese companies that are regulated
by the USFDA and has published an article of the
same title in a well-known Japanese magazine. Mr.
Yamaoka has a M.S. in Chemical Engineering and a
B.S. in Pharmaceutical Sciences.
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