Agalloco & Associates
P.O. Box 899
Belle Mead, NJ 08502
This course covers the range of sterilization processes utilized in the pharmaceutical, biotechnology and medical device industries. Sterilization methods to be covered in the course include: Steam sterilization for porous loads (fill parts, stoppers, utensils, etc); Terminal Sterilization for products, intermediates and media; Steam sterilization-in-place (SIP for tanks, freeze dryers, bioreactors, etc.); Dry heat sterilization and depyrogenation (ovens and tunnels); Gas sterilization for materials and equipment (medical devices and intermediates); Vapor and liquid sterilization (including isolator decontamination); Radiation sterilization (gamma, electron beam and other methods); Filtration sterilization for liquids; and Emerging sterilization methods.
An overview of the validation requirements for each of the sterilization methods will be provided. Regulatory expectations for compliance and submission applicable in the US and rest of the world will be included.
Who Should Attend
This course is intended for individuals requiring an in-depth knowledge using sterilization processes. Those experienced with sterilization technology can refine their knowledge of the subject through comprehensive treatment of the subject matter. Those without a background will learn the fundamentals of sterilization processes, before progressing into details of the sterilizing methods. The course is appropriate for personnel working in production, R&D, QA/QC, engineering, validation, microbiology, and regulatory affairs. Examples of applications for pharmaceuticals, biologics and medical devices will be utilized.
James Agalloco is President of Agalloco & Associates, a technical service firm to the pharmaceutical and biotechnology industry. Jim has 40+ years of industry experience and has worked in organic synthesis, pharmaceutical formulation, pharmaceutical production, project and process engineering, validation and process automation during his career at Merck, Pfizer, Squibb and Bristol-Myers Squibb. He is a past President of the Parenteral Drug Association and served as an Officer or Director from 1982 to 1993. He is a member of USP’s Microbiology and Sterility Assurance Expert Committee for 2005-2010. He is a frequent author and lecturer on the subject of sterilization, aseptic processing and process validation.
Russell Madsen is President of The Williamsburg Group, engaged in pharmaceutical consulting in the areas of CGMP compliance and auditing, quality systems, design review, aseptic processing and sterilization technology, sterile filtration, due diligence evaluation, process validation, and regulatory liaison. Prior to establishing TWG, Russ was employed by PDA, Bristol-Myers Squibb, Sterling Drug and Winthrop Laboratories. He is a member of USP’s Microbiology Expert Committee for 2010-2015, a member of Pharmaceutical Technology’s US Editorial Advisory Board, and PDA’s Science Advisory Board.
The course will be held at Rizzo Conference Center, owned by the UNC Business School and located at 150 DuBose House Lane, Chapel Hill, NC 27517. This extraordinary education center is just minutes from RTP, downtown Chapel Hill and Raleigh-Durham International Airport. Room reservations should be made directly with the Rizzo Conference Center. The Rizzo Conference Center can be reached at (919) 913-2098 or on-line at www.rizzoconfernececenter.com.
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