Sterilizing Filter Validation

Module Lenght

1 day

Agenda

  • International Regulatory Context
    • Requirements (PDA, EMEA and FDA)
  • Filter and Filtration process definition
  • Vendors and User Responsibility
  • Process Validation Studies
  • Process Review
  • Validation Test Overview
    • Bacterial Retention Studies
    • Compatibility
    • Adsorption
    • Extractables & Leachables
    • Product Wet Integrity Test (PWIT)
  • Toxicological Risk Assessment
  • Bracketing and Grouping
  • Process Revalidation
  • Future Regulatory Trends
  • Practical Workshop (Optional)

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

  • Eu cGMP Annex 1
  • FDA Guidance for Aseptic Processing
  • USP 37 NF 29 <1229>
  • ASTM F838
  • ICH Q7
  • PDA TR 26 “Sterilizing Filtration of Liquids”

Number of trainers

One/Two

Tailoring option available

Yes

Final evaluation quiz

Yes

Contact

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