Dr. Fleming, is a microbiologist/protein chemist with over thirty five years of experience in the healthcare industry in the areas of Quality Control, Quality assurance, Validation, Analytical Method Development and Validation, Analytical Instrument Development, and Process Development. He has extensive experience in pharmaceuticals, medical devices and clinical laboratory sciences. Pharmaceutical experience in aseptic processing, anti-neoplastic drug products, terminal sterilization of ampoules and vials, establishment of environmental monitoring programs for both sterile and non sterile drug products, OOS/CAPA investigations, cGMP and technical training, equipment and process validations including isolators, analytical instruments, ovens, depyrogenation tunnels, lyophilizers, etc. His Medical device experience includes contract sterilization, contract laboratory services, packaging, biological indicators, medical device manufacturing, environmental control and microbiologically related quality control, coordination of regulatory submissions and the coordination of regulatory inspections. Currently, employed by MedImmune, Inc. in the position of Senior Director for Corporate Microbiology. Over twenty years experience in clinical Microbiology directing Clinical Microbiology, Immunology and flow Cytometry Laboratories. Serving as a member of the PDA Task Force that is re-writing Technical Report 33 that deals with Rapid Methods in Microbiology.

Dr. Friedman is a Senior Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing Arena. During the past seven years, Dr. Friedman has been associated with Cambrex Bio Science Baltimore, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, MD. In that capacity as the Director, Quality Control, he managed a multi-shift Department of twenty eight individuals involved in client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity Dr Friedman enjoyed many client and regulatory interactions.

Prior to 2000, Dr. Friedman was the Laboratory Director for Chesapeake Biological Laboratories, a contract Aseptic Fill ‘n Finish manufacturer located in Baltimore, MD. In this capacity he was involved with the microbiology, environmental monitoring and analytical chemistry for Phase 1, 2, 3 and commercial products aseptically filled/lyophilized.

Dr. Friedman has over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include quality control, sterility assurance and fermentation technology. In addition to the associations listed above, other associations have included W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide.

Dr. Friedman received his B.S. degree in Microbiology from The Ohio State University, his M.S. from Michigan State University in Microbial Genetics and his Ph.D. from The Ohio State University in Microbiology.

Dr. Friedman is a frequent seminar speaker and specializes in the areas of aseptic processing for sterile drug products and the requirements for the manufacture of Phase 1, 2 and 3 clinical trial materials. He is a member of AAMI, ASM, PDA and RAPS. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President of the Capital Area Chapter, PDA.

Mr. Glogovsky is the Senior Business Development Manager for Pharmaceutical Microbiology at EMD Chemicals, the U.S. affiliate of Merck KGaA (Darmstadt, Germany). Some of his responsibilities include technical consultations, pharmaceutical laboratory start-ups as well as validation and technical assistance with EMD’s microbiology products including prepared and granulated culture media, MAS-100 air sampling equipment and irradiated non-animal products for aseptic processing simulations.
His past employment history includes the U.S. Department of Defense (TACOM-ARDEC), G&W Laboratories, and Chemunex. He is an active speaker in the pharmaceutical and microbiology industries and has published numerous studies and articles on rapid microbiology test methods, environmental monitoring and aseptic processing. He has also been involved with the PDA, PDA TRI, ASM and PRSM for the past 10 years.

Mr. Glogovsky has earned a Bachelor’s degree in Microbiology; a Master’s in Molecular Microbiology and is a certified Specialist Microbiologist in consumer and industrial microbiology (specializing in pharmaceutical products, medical devices and cosmetics) with the National Registry of Microbiologists. He is also a member of the PDA Mycoplasma Task Force.

Mr. Guardino is currently the Director of the Microbiology Lab for AAIPharma Inc. where he oversees a full-service contract Microbiology Laboratory in support of the Pharmaceutical and Biotechnology industries. After earning a Master of Science Degree from the University of Buffalo in Medical Technology with a concentration in Microbiology, he performed research in Microbiology and Biotechnology for several years and supervised an industrial microbiology lab for five years. Mr. Guardino has also held positions as a product development / quality assurance supervisor for rapid microbial diagnostics products, and as a principal scientist during the development of PCR-based diagnostic products for a J&J Company.

Jean E. Peart

Jean Peart is a microbiologist (McGill University) who is knowledgeable about drug manufacturing practices, quality control and regulation, specializing in biological drugs. She has significant drug industry experience acquired through employment as Plant Microbiologist prior to joining Health Canada and through frequent interaction with industry as senior management, regulator, drug submission evaluator and inspector on behalf of Health Canada. She has several years experience in biologic product testing and laboratory management and has conducted, as a carded inspector, regulatory inspections (nationally and internationally) of biologics manufacturing facilities for compliance to the Food & Drugs Act and Regulations.

Jean has also participated as an assessor, on behalf of the World Health Organization (WHO), in assessments of foreign National Regulatory Authorities, against WHO published benchmarks. Accredited as a technical assessor/auditor through a Standards Council of Canada (SCC) training course on the ISO 17025 Standard [Program for the Accreditation of Laboratories Canada (PALCAN)] she has been a member of several SCC audit teams.

Jean has very recently retired from her position of Laboratory Quality Assurance Associate/Special Advisor, Director General’s Office, Biologics and Genetic Therapies Directorate, Health Products and Food Branch, Health Canada.

Ms. Phillips is a professional microbiologist and is Associate Director, Quality Control at Human Genome Sciences, Inc. HGS is a biopharmaceutical manufacturing company located in Rockville, Maryland. Her current responsibilities include leadership and management of HGS' corporate microbiology team and program.

Ms Phillips brings with her over 20 years of microbiological control and testing experience in the fields of biopharmaceuticals, biologics, pharmaceuticals and medical devices. She has worked as at Millipore Corporation, Dade Behring, Ethicon (a subsidiary of Johnson & Johnson), BioReliance Corporation and Human Genome Sciences. Her experience and interests include fill/finish aseptic processing, microbiological control of product, processes and facilities used in the production of API manufactured in microbial fermentation and mammalian cell culture processes, quality control and lot release testing of biopharmaceuticals and biologics, biocontamination control, adventitious agents testing (i.e. bioburden, sterility and mycoplasma); validation of facilities, equipment, sterilization processes, and test methods; and global harmonization of compendial microbiological tests.

Ms Phillips is currently a delegate representing the United States to the ad hoc committee, ISO TC 209 Working Group 2, for ISO 14698-1, 2 (Cleanrooms and Associated Environments - Biocontamination Control) and has provided external review and technical support to the USP ad hoc committee on Mycoplasma testing.

James R. Rickloff, M.S.

James R. Rickloff is a Partner and Scientific Director for Advanced Barrier Concepts, Inc. in Cary, NC, which is in its’ 14th year of operation. He holds a Master’s Degree in Environmental Sciences and Engineering from Virginia Tech and obtained an in-depth sterilization background during a subsequent 12-year career at the American Sterilizer Company (AMSCO). His accomplishments include participating in the development of the VHP® Sterilization Technology and in demonstrating the effectiveness of hydrogen peroxide gas in decontaminating rooms, safety cabinets, and isolator systems in addition to obtaining several sterilization-related patents. Mr. Rickloff co-founded Advanced Barrier Concepts in 1994 to offer direct technical assistance to the pharmaceutical industry on the sterilization aspects and validation requirements for sterile isolator applications. He has given presentations on isolator decontamination issues at numerous conferences and seminars over the past 20 years.

Dr. Jaspreet Singh Sidhu is currently VP Business Development and Pharmaceutical Microbiology, Molecular Epidemiology, Inc. Prior to this position, Dr. Sidhu was Principal Scientist and Laboratory Research Director, and Senior Research Scientist for the University of Washington. Dr. Sidhu received his PhD in Biochemistry at the Brunel University and Max-Planck Institute for Biophysical Chemistry in Goettingen, Germany. He is a member of RAPS, PDA, and ISPE.