1773 Kings Road, Vista, CA 92084-3640, USA
Tel 1-760-941-2040 or 1-800-698-2040, Fax 1-760-301-0308, e-mail: info@cce-us.com  

    Anne Marie Dixon is the Managing Partner of Cleanroom Management Associates, a consulting firm that specializes in competitive benchmarking, training, and auditing of clean and aseptic operations and management.

     She has been actively engaged in the field of contamination control for over two decades with extensive experience in the areas of training, technical writing, strategic consulting, facility start-up, construction protocols and process optimization. She has trained over 150,000 cleanroom technicians and managers. 

     A University of Illinois graduate, she has published over ninety technical articles and three books including How to write a training manual published in 1997 by Micron Video International.

      Anne Marie was the first woman to be elected President of the IEST and was appointed to the position of FELLOW in 1998. She is the first recipient of the James P. Agalloco Award for Excellence in Training and is an active member of the PDA, IEST, ISPE, ASQ, SSA and AMA. She is also an ISO 9000 trained auditor.

      Anne Marie is the head of the U.S. Technical Advisory Group - TC 209 and represents the USA on the ISO Technical Committee 209 on Cleanrooms and Associated Controlled Environments

    Anne Marie teaches the CCE-courses

• Isolators, Cleanrooms and Controlled Environments

• Cleanroom Operation and Management

   Hubert Fleming, Ph.D. is an independent consultant who is nationally and internationally recognized as an authority in water treatment. He received his master and doctorate in chemical engineering from Cornell University.

    Hu has authored more than one hundred publications, eight book chapters, and sixteen patents in various aspects of chemical separations and purification. He is also the co-author of several books, including the Membrane Handbook, winner of the prestigious PSP Award for the Most Outstanding Work of Reference for 1992.

    Hu is a former Adjunct Professor at Stevens Institute, Worcester Polytechnic Institute and Carnegie-Mellon University. He is past chairman of the International Congress on Membranes and Membrane Processes, and is a member of several international professional panels on separation science and technology, as well as the ASTM D-19 Committee on Water Standards, and the Purified Water Working Group of the Parenteral Drug Association (PDA).

    Hu teaches the CCE-courses

• Pharmaceutical Water Systems - Design, Validation, Operation and Maintenance

• Total Water Management

        Jane L. Halpern, Ph.D., is Associate Director of Regulatory Affairs at the US office of ERA. Prior to joining ERA, Jane had been at FDA's Center for Biologics Evaluation and Research (CBER) for ten years where she was responsible for the scientific and regulatory review of products at all stages of development. This review work included pre-IND consultations, INDs, Product License Applications, and Establishment License Applications. Her regulatory activities included also participation in the FDA inspection program and involvement in the development of CBER's managed review process and regulation of biological products. She received her bachelors degree in physiology from UC Davis and her doctorate in pharmacology from the University of Rochester. 

    Jane is on the faculty of the CCE-course

• European Regulation of Biologics (Course Director: Christopher J. Holloway, Ph.D.)

    Frieder K. Hofmann, Ph.D. is Principal Consultant of ProCon International, an internationally operating consulting firm that provides comprehensive technical, regulatory and managerial advice in all areas associated with GMP-conforming pharmaceutical and biopharmaceutical manufacturing, product and process development, process engineering, validation, and facility design.     

    Since 1990, Frieder has worked as a technical, regulatory and quality systems consultant for both small start-up pharmaceutical and biopharmaceutical companies and multinational pharmaceutical concerns in the U.S., Europe and Japan. In this function he has performed numerous mock pre-approval and compliance inspections, has implemented or augmented GMP-conforming quality systems at both, start-up companies and multinational pharmaceutical concerns, has authored, assembled or reviewed the CMC sections and supporting documentation of regulatory submissions for IND's, NDA's and BLA's for various sponsors, has served as expert witness at court battles and has trained over 3,000 employees of healthcare manufacturers in U.S., European and Japanese GMP regulations, quality system design, documentation, process development and validation.  Frieder has also extensive hands-on experience in the planning and design of GMP-facilities and was responsible for the process scaleup and engineering, as well as the overall GMP-compliance, including validation, of various GMP-conforming pilot plant and production facility projects.

    Until 1990 he was Technical Director for BioTechnetics, San Diego, CA , where his responsibilities included the R&D of anticancer monoclonal antibodies and the GMP-conforming production scaleup of numerous cell-expressed proteins. Previous positions included European applications manager for a membrane manufacturer where he invented and developed a patented, automated upstream integrity tester for filters and three years of work in applied physics for the German pharmaceutical concern Hoechst A.G.

    His previous employer received the prestigious Kirkpatrick Chemical Engineering Achievement Honor Award in 1989 for Frieder's bioproduction technology. Frieder published numerous articles and authored two book chapters on pharmaceutical process technology. He is a frequent speaker and chairperson at national and international pharmaceutical and biotechnology conferences. 

    Frieder teaches the CCE-courses

• Biopharmaceutical Production Technology
• Recovery and Purification of Biopharmaceuticals
• Right, the First Time
• Documentation - Meeting the Regulatory Expectations
• Validation of Facility, Utilities, Equipment, Methods and Process
• GMP Compliance - Meeting the U.S. and International Regulatory Expectations
• Current Good Manufacturing Practices
• Contaminant Control in the Manufacture of Drugs and Biologics together with Carl J. Wilson)
• FDA-Regulated Ultrafiltration and Sterile Filtration
• Meeting the Technical Regulatory Requirements in Development and Manufacture of Biologics
• GMP-Supporting Manufacturing Facilities

   Christopher J. Holloway, Ph.D. is Managing Director of ERA Consulting (UK) Ltd. and Chief Scientific Officer of the ERA group. He has worked for over ten years in the field of European regulatory affairs, has specialized in biological products and has advised more than forty companies on product development and regulatory strategy in Europe. He has authored many expert reports for marketing applications in the European Union.

    Chris has an extensive background in biochemistry and biological science in addition to solid practical experience in drug development. Prior to setting up ERA Consulting he was managing director of International Bio-Research (IBR), a contract research company active in regulatory affairs, bioanalytics, toxicology and environmental science.

    Chris obtained his B.Sc. and Ph.D. degrees from the University of Surrey in the UK. In 1982 he was appointed as Professor of Clinical Biochemistry and Physiological Chemistry at the University of Hannover, Germany.

Chris teaches the CCE-course

• European Regulation of Biologics together with Jane Halpern, Ph.D.

    Kim L. Nelson, Ph.D. is Sr. Director of Bioprocess Technology with Clark Richardson & Biskup (CRB). He has more than ten years of experience in the design and operation of biopharmaceutical facilities, working with such companies as SmithKline Beecham, Genzyme, Amgen, Hoffmann-La Roche, Connaught, Scios, Syntex, Amvax, Serono Laboratories, Interpharm Laboratories, and Ciba Corning Diagnostics. 

    Kim received B.S. degrees in Chemical Engineering and Biochemistry from Oregon State University and his Ph.D. in Chemical Engineering from the University of Delaware. He taught for several years in the Department of Chemical Engineering at Arizona State University before entering industry where he headed the cell culture and fermentation process development groups at Otsuka Pharmaceuticals Ltd. and Flow Laboratories. In these positions he did large-scale anchorage dependent and suspension cell culture and pilot plant recombinant E. coli fermentation scaleup work.

    Kim's engineering design experience prior to joining CRB includes Life Sciences International, Quasar Engineering and United Engineers & Constructors. In his current position he continues to do conceptual and schematic design of pharmaceutical and biopharmaceutical projects and consulting on process development, biocontainment and Good Manufacturing Practices. He has attended numerous FDA preconstruction meetings on the behalf of clients.

    He is also co-editor of the book Bioprocess Engineering - Systems, Equipment and Facilities, Wiley Interscience, 1994.

    Kim teaches the CCE-course

• GMP-Conforming Pilot Plants and Production Facilities

    She received her Ph.D. in Experimental Pathology and a B.S. in Biology from the University of Utah. Prior to joining FDA, she conducted scientific research at the United States Army Medical Research Institute of Infectious Diseases at Fort Detrick, MD. Jeanne is an active member of ASM, DIA, RAPS, IABS, FDLI and PDA and a frequent speaker at regulatory conferences and seminars.
Currently, Jeanne is the Principal Consultant of CBR International where she provides expert regulatory advice on requirements for biological, pharmaceutical and device product development.

Carl J. Wilson is an internationally operating consultant providing services in the areas of Quality Assurance, Quality Control and Validation. For the past three years Carl has assisted biotechnology, medical device and international pharmaceutical companies operating in the United States, Hong Kong, Japan and Europe to develop Quality Systems to satisfy GMP, QSR and ISO requirements. Areas of expertise include development of raw material and product specifications and corresponding analytical and microbiological testing programs, stability programs, calibration and maintenance programs and monitoring programs for water systems, cleanrooms and utilities. He also has extensive experience auditing manufacturing/fill/finish facilities, product testing laboratories and distribution operations.

  Prior to 1995, Carl managed Quality Control departments at Cytel Corporation and Invitrogen in San Diego. At Cytel, his responsibilities included development of programs for raw materials qualification, analytical methods transfer and validation and oversight of animal and microbiological safety testing for sterile injectable therapeutic antibodies, carbohydrates and peptides. At Invitrogen he was responsible for developing systems for qualification and stability testing of critical raw materials and kits developed to assist researchers in the field of molecular biology Carl received his B.A. and M.A. degrees in biology and microbiology at California State University. In 1984 his graduate research project placed first in the Southern California Graduate Student Colloquium sponsored by the American Society for Microbiology. He is currently a member of the American Society for Microbiology, PDA and ISPE.

• Contaminant Control in the Manufacture of Healthcare Products together with Frieder K. Hofmann, Ph.D.

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