Agalloco & Associates
P.O. Box 899
Belle Mead, NJ 08502
This course will provide comprehensive coverage of aseptic processing reviewing basic principles, technology choices, process design, environmental monitoring, and process simulation. The core technology of sterilizing filtration will be covered in depth. The last day of the course will address aseptic processing risk management, contemporary regulatory expectations and future technologies process. The course will draw upon FDA’s 2004 Guideline on Sterile Drug Products Produced by Aseptic Processing and EMEA’s – Annex 1 on Sterile Medicinal Products. There will be ample time for interactive discussion among the students and instructors on the topics being presented.
Who Should Attend
This course is intended for individuals involved with or considering the use of aseptic processing. Those experienced with aseptic processing will refine their knowledge of the subject through interaction with industry experts. Those without a strong background will learn the basics and develop an understanding of the more advanced considerations. The course is appropriate for personnel working in QA/QC, production, engineering, validation, and microbiology.
James Agalloco is President of Agalloco & Associates, a technical service firm to the pharmaceutical and biotechnology industry. Since the formation of Agalloco & Associates in 1991, Jim has assisted more than 100 health care firms in a wide range of validation, automation and compliance areas. Jim has over 35 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 received his BS in Chemical Engineering from Pratt Institute in 1968 and his MS, also in Chemical Engineering from Polytechnic Institute of New York in 1979. He received his MBA in Pharmaceutical Studies from Fairleigh Dickinson University in 1983. 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.
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