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Author's Profile

*No updation since edition.
*All in random order.

A

  • Charles I. Ahn

    Charles I. Ahn

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    Aegis Managing Director, Aegis Beacon Consulting, LLC
    Lecturer at Peking Univ. (Pharmaceutical Eng. Management Masters Program)
    In the 27 years of career of Mr. Ahn with FDA (1986-2012), he had worked as Investigator, Compliance Officer, Inspection Program Expert, Enforcement Case Management Officer and the Assistant Country Director of the newly created Agency’s China Office (2009-2011). He was a member of the working group for establishment of FDA’s regulatory policies such as API guidance, new cGMP regulations, electronic records regulations, manual recognition agreement with EU, and FDA intern-office GMP policy. For all those years, he had also continuously participated in inspections of various pharmaceutical manufacturing facilities, including for APIs or finished dosage forms, complex computerized systems, and non-sterile or sterile operations.
    After retirement from FDA in 2012, he has been providing advisory opinions and training on GMP to many pharmaceutical companies with his multi-cultural background.

C

  • Vincent H. Chang

    Vincent H. Chang(Ph.D. (Org. Chem.))

    All the author's articles

    M.D., Yili Consulting LLC
    Following B.Sc. in Taiwan, Dr. Chang received his Ph.D. from Duke Univ., USA. After he worked as research scientist for 9 years, he joined Abbott, Chicago in 1990. He was responsible for quality operations in Pacific Asia, Australia, Africa and Japan, then, finally appointed as QA Director responsible for contract operations. He joined Yili in 2015 and provides multi-cultural consulting services to lead strategic plans for NDA, SNDA, DMF and PAI as per FDA, EU, TGA, ANVISA, WHO and PIC/S.

  • CM Plus Bio-Eng G

    All the author's articles

D

  • Daniel Price

    Managing Director, QSight Ltd.
    Worked in the pharmaceutical industry for more than 18 years in various validation areas, including software validation, computerized system validation and equipment validation. Roles have included validation leader, project manager, validation expert, test leader, trainer, auditor and others. Previous role was the QA manager for information systems at a multi-national pharmaceutical company. Prior to this role, worked as a senior consultant for equipment and systems validation at a pharmaceutical consultancy firm. Expert knowledge in FDA Part 11 and computer system validation regulations, Japan PMDA ERES and Computer System Guidelines, GAMP5, PIC/S computer system validation guides, EU GMP Annex 11, GCP/GVP/GPSP system validation and GxP system data integrity.

F

  • Gordon J.Farquharson

    Gordon J.Farquharson

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    Principal, Critical System Inc.
    Based in U.K., Farquharson offers consultancy services mainly in Europe, ASEAN countries and Australia. With extensive knowledge of the standards set by regulatory authorities for the pharmaceutical industry and of industry trends, he can offer focused advice on the GMP requirements of the EU, PIC/S, WHO and FDA.

  • Kunihiko Furuzawa

    Kunihiko Furuzawa

    All the author's articles

    Furuzawa joined Sumitomo Chemical in 1978 to work on drug discovery and safety, and then joined Mitsui Norin in 2004 as compliance manager of the API manufacturing division to take charge of GxP audits for vendors, until he left the firm in 2014.
    Furuzawa's areas of practical expertise include GMP (GxP) audits, risk assessment, GMP management (production management, quality assurance/management, document management), risk analysis, and PMDA/FDA inspections.

  • Factorytalk: Specialist GMP Compliance & IT experts for regulated industries
    http://www.factory-talk.com/

    Factorytalk are a leading supplier to the Pharmaceutical, Biotech, Medical Device, and other GxP/ISO regulated industries. We operate across the world, and are headquartered in Bangkok, Thailand. Our team is comprised of local and international professionals with vast experience of both regional and global projects.

    We pride ourselves in having the right people to bring leading international standards, technology, and techniques, to projects for any size of company. Delivered with the experience required to navigate complex company cultures and needs, whether a multi-national, regional, or local customer.

G

I

  • Nobuaki Ishii

    Nobuaki Ishii(PhD. engineering)

    All the author's articles

    Professor, Bunkyo University Faculty of Information and Communications
    Ishii was born in Yokohama City, Kanagawa Prefecture in 1959.He joined JGC Corporation in 1984, after finished Graduate School (Industrial Engineering and Management) of Tokyo Institute of Technology.He had been in charge of the energy section, commercialization plan of pharmaceutical sector, facility planning, planning, designing and introduction of information system for production and product management. He also worked at U.S. Purdue University IE Faculty as Visiting Fellow. From 2005 He has been worked in Bunkyo University Faculty of Information and Communications.He is also the commissioner of The Society of Project Management and the commissioner of Information Systems Society of Japan.

L

  • Fei Li

    After graduated from Tsinghua University in 1999, Mr. Li got his undergraduate education majoring in biomedical engineering in University of Pennsylvania and graduation in 2003. Then he entered Philips and Neusoft Medical Systems Co., Ltd in Shenyang China, and worked on researching and developing medical devices. In 2005, he joined Technology Evaluation Center of Liaoning Food & Drug Administration as manager of Medical Device Division.

M

  • Anri Morikawa

    Representative of Anri Consulting
    He joined Asahi Kasei in 1977. He had been consistently engaged in research of synthesis of screening compounds and process chemistry, and awarded a PhD during this period.
    In addition, he also dealt with the production of investigational drugs such as anticancer drugs and the inspection by the competent authorities of the U.S., Italy, Australia and Korea during he was a plant manager of bulk drug for 10 years.

N

  • Atsushi Nunome

    Atsushi Nunome

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    Nunome Professional Engineer Office
    Professional Engineer:Industrial Health Engineering (Water quality control )
    Nunome joined Kurita Water industries in 1972. He moved to Nomura Micro Science Co., Ltd in 1992 and has been engaged in consultation work as a specialist in pharmaceutical water.

R

  • Ririn afrianti

    Ririn afrianti

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    CMPlus Consulting Indonesia
    Graduated from Pharmaceutical Science and Industry, Gadjah Mada University, Indonesia in 2012 and awarded with the title of “Best Scholar” from the same University when she continued her study in Apothecary Profession. Then she was joined PT Fonko International Pharmaceuticals, one of member of Dexa group (which is known as one of the biggest pharmaceutical Industry in Indonesia) which is focusing on Sterile Oncology Manufacturing. She has experienced to perform Qualification, Validation, Warehouse Management, Production Planning and Inventory Control, and responsible for all quality related activities in coordination with Quality Manager. In the early of 2017 she joined CMPlus Consulting Indonesia as an Assistant Consultant.

S

  • Sundoro Iswanto

    Sundoro Iswanto

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    Iswanto had worked as an Area Sales Manager regarding Infant food formula at PT. Mirota KSM Inc. to 1985. Then he joined PT. Pfrimmer Infusol Indonesia as a Production Manager and produced Large Volume Parenterals (LVPs) as well as Small Volume Parenterals (SVPs). After that he joined at PT. Triyasa Nagamas Frama as a Production Manager and produced aseptic family planning hormones vials and oral anti-baby pills.
    In 1993 he joined at Roche Indonesia and had been engaged in a Plant Manager producing tablets, oral liquid, semisolid and sterile anti- neoplasma until 2004. He was engaged in PT. Bayer Indonesia as a Site Manager regarding OTC medicine. After he retired, He has worked for several pharmaceutical companies as a freelance consultant.

T

  • Osamu Takahashi

    Osamu Takahashi

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    Sakura SI CO. LTD. Scientific Advisory
    Takahashi joined Nippon Lederie Corporation (now Pfizer, Inc.) in 1973.
    He had been in charge of manufacturing of pharmaceuticals, research and development, sterile investigational products manufacturing, sterile products manufacturing and quality assurance. He moved to Sakura Seiki Co., Ltd. that is a sterilization equipment manufacturer, and had been responsible for development of the sterilization equipment and scientific support with regulatory affairs.
    He has been incumbent since 2011. He had been engaged with the development of ISO standards of ethylene oxide gas and moist heat sterilization validation since 2000, as International Committee of the ISO / TC198 involved in the sterilization of health care products and responsible for Drafting Committee of JIS standardization of the relevant ISO standards. He also served as the JIS drafting Commissioner of ethylene oxide gas and moist heat sterilization equipment.

  • Masayuki Takahira

    Masayuki Takahira(Ph.D.)

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    Representative of Aid Pharma
    Adviser of NPO-QA Center
    Mr. Takahira entered Shionogi & Co., Ltd in 1979 and accumulated plentiful experience of pharmaceutical production and quality assurance. He had contributed to the GQP/GMP/QMS/CMC compliance and GQP/GMP/QMS compliance audit of the 170 pharmaceutical plants in Japan and overseas relevant to Shionogi’s products for nearly 10 years. He has also participated in partial and minor production/test method change applications, product management and documentation customization for quality assurance complying with domestic and overseas GMP. He had been appointed to an executive as a product strategist at Ace Japan Co., Ltd since December 2011. He was engaged in the quality assurance, production/test, marketing relating affairs of API and intermediates from management perspective. He took up his current position in Jun 2016.

  • Shigehiro Tahara

    Shigehiro Tahara

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    CM Plus(Singapore)Co.,Ltd. Managing Director & COO
    CM Plus Vietnam General Director & COO
    Tahara joined a major engineering company in 1982. After working on process design and test-runs of overseas oil refineries and LNG plants, he focused on production facility management, including management of pharmaceutical production facilities. He has consulted for drug manufacturing facilities and performed numerous GMP assessments. He joined CM Plus in March 2008, and took up his current position at the company in February 2014.

  • Le Van Truyen

    Assoc. Prof., Ph.D. Former Vice Minister of Health. Senior Advisor (Pharmaceutics)
    Dr. Le Van Truyen received Ph. D. degree (Pharmaceutical Sciences) from Bucharest University of Medicine and Pharmacy. (Romania, 1971). From 1971 to 1986, he worked as a lecturer in Pharmaceutical Technology at Hanoi University of Pharmacy. From 1986 to 1990, he joined Thua Thien – Hue Pharmaceutical Manufacturer as a Deputy Director, and was promoted Director in 1989. From June 1992 to 2002, Dr. Truyen was Vice Minister of Health as well as a Deputy of Vietnam National Assembly. In June, he retired.
    Dr. Truyen founded Viet Nam Pharmaceutical Companies Association (VNPCA), and was the very first President of VNPCA from 2000-2004. In 2005, he joined Savipharm Project (SVP), one of the leading pharmaceutical manufacturers of Viet Nam, and was one of the key persons supporting it to receive J-GMP Certificate in 2010. At that time, he was Chairman of Science Technology Committee of SVP cum Vice General Director (Science-Technology-Production and Quality Management) from 2009-2012.
    So far, Dr. Le Van Truyen has been a Visiting Professor at many Universities of Pharmacy in Viet Nam and involved in consultation as well as training in GMP and research activities in pharmaceutical sector. He was also the senior expert of UNIDO in Viet Nam (2010-2013), short-term advisor of World Health Organization (WHO) Geneva and Ha Noi.
    Dr. Le Van Truyen has joined CM Plus Vietnam as Senior Advisor from December 2014.

V

  • Chris Vickrey

    Chris Vickrey joined MSA in 2001. In 2003 he launched US Pharmaceutical Industry Weekly Report, a report in Japanese on developments in the US pharmaceutical industry. In 2004 he became president of the company. For MSA’s own publications and on behalf of clients, he has interviewed hundreds of biopharmaceutical executives, academic researchers, and government officials on issues ranging from business strategy to scientific discovery and public policy. He has BA/MA degrees in economics from Boston University and an MBA in finance from Columbia University. He is proficient in Japanese.

W

  • Jon R. Wallace

    Jon R. Wallace

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    Wallace worked for 10 years with FDA as a consumer safety officer and 17 years for pharmaceutical and biotechnology companies in USA occupying operational positions responsible for QA and FDA GXP compliance. Wallace has been offering in these 12 years consulting services to cover an extensive domain from biotechnology, pharmaceutical drugs to medical devices inclusive of helping a Japanese pharmaceutical company for FDA inspection successfully.

Y

  • Akiko Yamaguchi

    Akiko Yamaguchi

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    President, T.T.T. Studio Ltd. Tokyo
    After working as an interpreter/translator for a foreign pharmaceutical company, and subsequently as a freelance, Yamaguchi founded T.T.T. Studio Ltd Tokyo in 1998.
    Yamaguchi has an extensive experience of over 30 years in pharmaceutical interpreting and translation including attendance to FDA inspections, mock inspections, and other authorities inspections. Have translated entire CGMPs, validation documents, clinical trial reports, CMCs, DMF related documents, etc.

  • Lily Yu

    Representative of CM Plus Corporation China Liaison Office, GMP Platform Consultant
    After Lily graduated from Shenyang Pharmaceutical University in 2005, she entered a big Japanese engineering company. As a validation engineer of GMP Department, Lily took part in Japanese Pharmaceutical companies' new factories construction project and worked on validation and DQ/IQ/OQ documentation. In 2010, Lily joined in Shanghai Tofflon Science and Technology Co., Ltd. and worked as International Affairs Director to coordinate the cooperation with Japanese companies. Then, Lily joined CM Plus Corporation in 2013.
    Lily has taken part in PMDA'S GMP inspection to Chinese API plant as an interpreter for several times. Lily can speak Chinese, Japanese and English.In 2018, she took part in 'Seminar on GMP Inspection sytem in Japan' held by China FDA(now NMPA) as a member from Japanese GMP consulting company.

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