Single Use System Qualification and Validation

Module Lenght

1 day

Agenda

  • International Regulatory Context
    • Requirements (PDA, EMEA and FDA)
    • Material Qualification Documentation
    • Single Use Equipment Process Validation Requirements
  • Process Validation Studies
  • Process Review
  • Validation Test Overview
    • Compatibility
    • Adsorption
    • Extractables & Leachables
    • Stability Studies
  • Toxicological Risk Assessment
  • Bracketing and Grouping
  • Process Revalidation
  • Future Regulatory Trends

Target audience

  • Quality Assurance
  • Quality Control
  • Regulatory Affairs
  • Technology Transfer
  • Validation
  • R&D

Learning tools

  • Presentations
  • Lectures
  • Case Studies
  • Discussion
  • Question & Answers session
  • Final Evaluation Test

Regulatory & technical references

  • ICH Q7
  • USP <87>,<88>,<660>,<661>,<1660>, <1663>,<1664>
  • PDA TR 66 ” Application of Single-Use Systems in Pharmaceutical Manufacturing”
  • PQRI publication: Safety thresholds and best practices for extractables and leachables in Orally Inhaled and Nasal Drug Products
  • ASTM E2097-00 (2006): Standard guide for determining the impact of extractables from non-metallic materials on the safety of Biotechnology Products

Number of trainers

One/Two

Tailoring option available

Yes

Final evaluation quiz

Yes

Contact

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