James (Jim) Akers, PhD, is president of Akers Kennedy & Associates, Inc., located in Kansas City, Missouri, USA. He has more than 25 years experience in the pharmaceutical industry and has worked at various director level positions within the industry, and for the last decade as a consultant. He served as president of the PDA from 1991 to 1993, and as a member of the PDA board of directors from 1986-1999. Currently, he is chairman of the USP Committee of Experts Microbiology/Sterility Assurance. He has served as co-chairman of the PDA Isolator Technology Task Force, Aseptic Processing Task Force and member task forces revising technical reports #13 and #22. Lecturing worldwide, he has taught numerous pharmaceutical technology courses worldwide including training for the US FDA. He also authored 14 textbook chapters, edited a book on isolation technology, has a second book on isolator technology in preparation, and authored more than 100 technical and review articles on 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.