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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:

Good understanding of processes in biomanufacturing/pharma/food production, quality assurance, and quality control within the context of Good Manufacturing Practices (GMP). Certification or at least 1 year of experience in production/management)

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