The Third Stage of Product Life Cycle: What You Should Know About Cleaning Validation Maintenance
The recent shift from traditional validation to a multi-staged life cycle approach emphasizes the requirement for scientifically sound decisions in the design, qualification, and monitoring of cleaning processes. For both new and existing manufacturing process systems should be placed to supplement any validated cleaning program regardless of the extent of pre-validation work. GMP manufacturers must at least assess the risk of the current cleaning procedure and provide assurance that it performs as validated and remains in a state of control for the life of the product(s) being manufactured. Failure to establish an adequate ongoing monitoring program is probable to result in sanctions from health authorities. This presentation will assist in understanding regulatory trends and rationale. Case studies will be included throughout the presentation, while addressing the following elements: tools for continuous monitoring, establishing process controls and periodic review.
This is a virtual, online-only program.
Speaker:
Elizabeth Rivera has 20 years of experience and traveled to places in North America, Latin America and Europe to support pharmaceutical manufacturers in various aspects of cleaning and decontamination. She has extensive experience in cleaning validation programs, selection of detergents, disinfectants and sterilization assurance products including the application and use of these in the pharmaceutical, biopharmaceutical, cosmetics, medical devices, dietary supplements, and related industries. She has published articles related to cleaning and microbial control. She has a bachelors and master’s degree in chemical engineering from the University of Puerto Rico.
Registration Information:
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COST |
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ISPE Members |
$15 |
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Non-Members |
$35 |
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Emerging Leader/Student |
$15 |
Register now!