Elements of a High Quality Aseptic Filling Program

Venue: Coronado

Location: Coronado, California, United States

Event Date/Time: Jan 11, 2009 End Date/Time: Jan 11, 2009
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Elements of a High Quality Aseptic Filling Program
Developing a good quality aseptic program at your facility may appear to be a daunting enterprise. Regulations are tightening, and the ability to run an aseptic operation in a quality manner while maintaining efficiency is often looked upon as difficult. However, utilization of effective quality practices can actually provide anappreciable improvement in efficiency as well. This session will discuss the basic elements of a high quality aseptic program. The discussions will include a review of
efficient batch record generation, facility disinfection, gowning, autoclaving, and cleanroom behavior. Attendance at this seminar will inform the audience on high
quality and effective ways to perform each of the following:

How to create good, clear batch records, and their importance to the quality process
How to train for the gowning process
How to train for clean room behavior
How to efficiently sterilize disinfection tools and materials
How to efficiently sterilize machine parts
How to develop the zero-failure mind set

Course Instructor:
Robert J. Pallo, B.A., M.A.M., Manager, PSO Fill and Finish Operations, Allergan