Rapid Microbiology

Module Lenght

half a day

Agenda

  • History of microbiology methods
  • International regulatory context overview
  • Rapid Microbiology technology overview
    • Growth Based
    • Viability Based
    • PCR based
  • Validation Strategies
  • Rapid Method Qualification
    • IQ
    • OQ
    • PQ

Target audience

  • Quality Assurance
  • Quality Control
  • Validation
  • Manufacturing

Learning tools

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

Regulatory & technical references

  • USP <1223> validation of alternative microbiological methods
  • Eph 5.1.6 Alternative Methods for Control of Microbiological Quality
  • GMP Annex 15
  • PDA TR 33 Evaluation, Validation and. Implementation of New Microbiological Testing Methods

Number of trainers

One

Tailoring option available

No

Final evaluation quiz

Yes

Contact

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