The Life Cycle Approach to Cleaning Validation 2020

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This seminar will cover the aspects, procedures, rules and limits regarding cleaning validation in the pharmaceutical industry. Why FDA requires a cleaning validation program and which equipment must be tested will be discussed. How to plan a cleaning validation program, select which substances to focus on, write procedures for cleaning equipment and prepare cleaning validation protocols will be covered. How to calculate maximum allowable carryover (MCA), Surface Acceptance Limits (SAL), Therapeutic dose, Surface Contamination level, Swab residue, No Observed effect level (NOEL), and Acceptable Daily intake (ADI) will be explained. Sampling techniques and their validation, as well as analyti...cal methods and their validation will be covered. How to write a cleaning validation report and how to document decision regarding new products will be reviewed. Recent Warning Letters and Inspection Observations from FDA will be used to discuss what not to do. Mehr lesen