Biomanufacturing - Bio003 - Principles of Validation
Principles of Validation is led by an expert in validation in pharmaceutical and bio-manufacturing environments, and provides the participant with a high-level overall view of the validation application and requirements with added focus on the most critical elements of validation.
About the program
The following topics are covered:
- Quality system and the foundations of qualification/validation / the definition
- Evaluating the need for qualification/validation
- Document structure (FSDS, URS up to PQ)
- Utility/building qualification
- Equipment qualification
- Cleaning validation
- Process validation
- Methods validation
- Software/computer validation
- Validation application
- Conclusion
Prerequisites
Recommended background: |
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Target Audience | Graduating students (biomanufacturing), professionals in support areas of production operations and researchers looking for an introduction to the topic of validation techniques. Refresher for operators in the field. |
Course Attestation and Professional Development