Solution preparation and Filtration

Module Lenght

from 1 day and a half to 2 days

Agenda

  • Regulatory aspect from International Agencies
  • Technical Background from cGEP (Good Engineering Procedures)
  • Validation Life Cycle
    • Design Qualification
    • Installation Qualification
    • Operational Qualification
    • Calibration
    • Performance Qualification
  • Operational and Maintenance Aspects

Target audience

  • Engineering
  • Validation
  • Maintenance
  • Manufacturing

Learning tools

  • Presentations
  • Lectures
  • Case Studies
  • Discussion
  • Question & Answers session
  • Final Evaluation Test
  • EU cGMP – The rules governing medicinal products in the European Union “Good manufacturing practices”
  • PIC/S GMP
  • WHO GMP
  • USA GMP – CFR21 Parts 210,211
  • ISPE – Baseline Vol. 2 “Oral solid dosage forms”
  • ISPE – Baseline Vol. 3 “Sterile Products Manufacturing Facilities”
  • ISPE – Baseline Vol. 7 “Risk-Based Manufacture of Pharmaceutical Products”
  • FDA Guidance for Industry “Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice”
  • PDA – TR 61 “Steam in Place”
  • EMA ICH Q7A “Note for Guidance on GMP for Active Pharmaceutical Ingredients”
  • FDA ICH Q7A  “GMP Guidance for Active Pharmaceutical Ingredients”
  • ASME BPE 2014 Bioprocessing Equipment

Number of trainers

One

Tailoring option available

No

Final evaluation quiz

Yes

Contact

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