Risk Management in Aseptic Processing

Venue: Online

Location: Web Based, United States

Event Date/Time: Dec 11, 2008
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Description

Assuring the microbiological control over a product during manufacturing is a critical function of the aseptic process, with reducing the potential opportunity for contamination crucial to the success of the manufacturing process. Risk analysis can help meet both regulatory and quality issues in aseptic processing, and can provide valuable tools to assure the sterility of your product.

This comprehensive live and interactive web seminar will discuss the aseptic process from a microbiological point of view and discuss how to use risk tools to optimize the aseptic process. Several potential opportunities that could result in contamination will be reviewed, including personnel, equipment design, environmental control, risk analysis of the aseptic process, and training roles. A case study will also be provided during this presentation.



Discussion Points will include:



Learn about global regulations for the aseptic process
Review the various guidelines
Understand the contamination issues in the typical aseptic process
Use risk analysis tools to optimize process flow
Learn industry best practices
Provides information on the benefits of risk analysis

Venue

Additional Information

Speaker Bio Dr. Frank S. Kohn is President of FSK Associates, Inc., an international consulting company providing services to the pharmaceutical, biotechnology and vaccine industries. Frank retired from Wyeth, where he was Director of Manufacturing at the Sanford, North Carolina facility.

Types