Hygienic equipment design: A risk-based approach to hygienic equipment design by looking into factors that can alter the quality and safety of the drug products and how to avoid these by choosing the right equipment design. References will also be made to ASME BPE and their recommendation for equipment design.
Cleaning validation: An 8-step approach and explanation on how to perform cleaning validation. 1. Decide residues to consider. 2. Introduction to acceptable residue limits. 3. Investigate if bracketing and grouping is possible. 4. Decide suitable sampling techniques. 5. Make recovery studies. 6. Calculate acceptable limits for the sampling technique. 7. Select suitable analytical methods. 8. Validate the system.
Water for Injection: Exploring the differences between cold and hot WFI water generation with capital and operations cost and risk factors analysis based on standard compendial water packages.

1. to learn how to perform cleaning validation.
2. to learn how to choose the right equipment design for quality and safety of the drug.

cleaning validation, hygienic equipment design, risk-based approach

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