James E. Akers, PhD

Colleen M. Kennedy

Validation Services

 

Shibuya in association with Akers Kennedy & Associates have pioneered validation services in Japan and have currently completed several hundred validation projects.

Scope of Shibuya Validation Service

  • Design Qualification (DQ)
  • Planning and executing Installation Qualification (IQ) and Operation Qualification (QC) including the development of protocols and carrying out calibrations
  • Planning the Sterilization Qualification (SQ) protocols and assisting in the execution
  • Assisting in the preparation of Standard Operating Procedures (SOP)

 

Management Profiles

James E. Akers, PhD

Dr. James Akers has over 21 years Pharmaceutical Industry experience at Director level and has for the past decade worked as an industry Consultant. Dr. Akers served as the President of the PDA from 1991~93, and has served on the PDA Board of Directors from 1986~1999. Dr. Akers is currently a member of the USP Committee of Experts in Microbiology, as well as being Co-Chairman of the PDA Isolator Technology Task Force, the Aseptic Processing Task Force and a member of several other recent program committees.

Dr. Akers has lectured World-wide, and has taught numerous pharmaceutical technology courses, including training for the US FDA. Dr. Akers has authored eleven text book chapters, edited a book on Isolation Technology, with a second book on Isolator Technology in preparation. Dr. Akers has also authored more than 100 technical and review articles covering a variety of subjects including, validation, aseptic processing, contamination control, environmental monitoring and control, biotechnology, isolator technology, sterilization and disinfection, sterility testing, media fill testing, HACCP analysis, pharmaceutical microbiology and regulatory compliance.

Colleen M. Kennedy

Ms. Kennedy has more than twenty-four years experience in the biological and pharmaceutical industries. She has experience in biological vaccine production and management, and the product and process improvement of these products. Ms. Kennedy has also worked in research and development of new biological products, particularly on the purification of proteins. As a Manager of Technical Services and validation Departments she was responsible for project management, including validation, calibration, change control and technology transfer.

Ms. Kennedy earned an MBA in Management from Loyola University, New Orleans, and a BS in Biology from Ramapo College, New Jersey. Ms. Kennedy has conducted several training seminars on GMP compliance, validation procedures and isolation technology, both domestically and internationally.

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