Agalloco & Associates
P.O. Box 899
Belle Mead, NJ 08502
This course reviews methodologies for the design and execution of validation studies for development, scale up and commercial preparation of drug products and drug substances. 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 validation activities for drug products and drug substances. Those experienced with validation will refine their knowledge of the subject through interaction with industry’s leading expert. Those without a strong background in validation will learn the basics and develop an understanding of the more advanced considerations. The course is intended for personnel working in validation, research & development, pharmaceutical, BPC and biotechnology production, quality assurance and regulatory affairs.
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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