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Madhu Raju Saghee, M.Sc - Madhu Raju Saghee is working in corporate quality and sterility assurance department at Gland Pharma Limited, a producer of small volume parenterals located in Hyderabad, India. In this position, he is responsible for implementing a robust quality system, review of sterility assurance validation documents for all regulatory submissions, ensuring micro compliance and involved in qualification and validation of sterile and aseptic manufacture for parenterals. He has written many articles pertaining to regulatory compliance, quality assurance, quality risk management, cleanroom contamination control and microbiology. He is the co-author of IDMAs technical monograph, "Environmental Monitoring in Cleanrooms". Raju has a Master of Science in Microbiology from Andhra University and Master of Science in Chemistry from Nagarjuna University.

Tim Sandle, Ph.D, CBiol, MSBiol. - Dr. Sandle is the Head of Microbiology at the UK NHS Bio Products Laboratory. Dr. Sandle is a chartered biologist and holds a first class honors degree in Applied Biology; a Masters degree in education; and obtained his doctorate from Keele University. His role involves overseeing a range of microbiological tests, batch review, microbioiogicel investigation and policy development. In addition, he is an honorary consultant with the School of Pharmacy and Pharmaceutical Sciences, University of Manchester and s a tutor for the university's pharmaceutical microbiology M.Sc course. Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards). He is currently chairman of the PhorMIG LAL action group arid serves on the UK Blood Service cleaning and disinfection committee. He has written over eighty book chapters, peer reviewed papers and technical articles relating to microbiology. He is currently the editor of the Pharmaceutical Microbiology Interest Group Journal and runs an on-line microbiology forum. Dr. Sandle is an experienced auditor and frequently acts as a consultant to the pharmaceutical and healthcare sectors.

Edward C. Tidswell. PhD - Dr. Tidswell is the Senior Director of Sterility Assurance for Baxter Healthcare; located north of Chicago, IL (USA), Responsibilities include: Leading Baxter's research, development and implementation of new (or optimized) sterilization and aseptic technologies, qualification and validation of sterile and aseptic manufacture for parenterals and medical devices. His organization supports more than 40 facilities in this global strategic and tactical role. He has worked within bulk active pharmaceutical ingredient, vaccine and parenteral manufacturing operations for human health and animal health products in both technical and validation roles for the likes of Eli Lilly and Evans Vaccines. Dr Tidswell continues to actively publish and is a leading authority on risk, aseptic and sterile manufacture. In 2004 be received the Parenteral Society's George Sykes Memorial Award for his contribution to pharmaceutical risk assessment As a microbial physiologist Dr Tidswell retains an active interest in several areas of microbiology, which include: bacterial adhesion, quorum sensing, viability, anaerobes, and rapid microbial technologies. Since 1994 he has served on the Editorial Boards of Letters in Applied Microbiology and The Journal of Applied Microbiology In June 2010, Dr. Tidswell joined the USP expert committee on Microbiology and Sterility Assurance.