חדש

מיקרוביולוגיה בייצור לא סטרילישיקולי איכות בייצור של תכשירים רפואיים

Microbiological Quality Considerations
in Non-Sterile Dosage Forms Manufacture

בהדרכת: גב' קרן גינסבורי
גרסה להדפסה

שתף קולגה:

The objective of this course is to understand microbiological concerns from a process, product, patient and regulatory perspective:

  • To be able to review processes
  • To identify microbial hazards
  • To put in place appropriate controls

The objective of this course is to understand microbiological concerns from a process, product, patient and regulatory perspective:

  • To be able to review processes
  • To identify microbial hazards
  • To put in place appropriate controls
    • Microbial Control Strategy
    • FDA Draft Guidance on Microbiology for Non-Sterile Drugs
    • USP / Ph Eur General Microbiology Chapters:
      • <1111> Microbiological Examination of Non-Sterile Products
      • <1112> Application of Water Activity in Determination of Non-Sterile Pharmaceutical Products
      • <1231> Water for Pharmaceutical Purposes
    • USP/Ph Eur Monographs:
      • <60> <61> <62> Microbiological Tests for Non-Sterile Products
      • Environmental Monitoring vs. Microbial Limit Test (vs. Bioburden)
סגור
תאריכים: 
  • 14/02/2024
  • 21/02/2024
מיקום הקורס: היברידי: כפר המכביה, רמת גן או ZOOM
משך הפעילות: 2 ימי לימוד
שעות: 17:00 - 09:00
נקודות זכות: 2
שפת הקורס: עברית

עלות הקורס המלאה: ₪4,600 + מע"מ
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מה תכני הקורס?

  • What is a control strategy for microbial risks
  • Contamination prevention vs. mopping up the mess
  • FDA’s draft Guidance on Microbiology for Non-Sterile Drugs
  • EU Annex 1 for Sterile Products – applicable or not?
  • WHO Guides? (HVAC for non-sterile manufacturing, other?)
  • The pharmacopoeias: general chapters – process vs. product monographs
  • The role of Environmental Monitoring
  • Cleaning and Disinfection
  • Recent inspection findings PIC/s Concept Paper on revision of Annex 11
  • What awaits industry in future inspections?
  • Quality Unit role vs. rest of management
  • Interactive Group Activity:
  • Develop a framework for a microbial control strategy in small groups for different types of non-sterile dosage forms

למי זה מתאים?

  • API / Drug Substance and non-sterile Finished / Drug Product manufacturers
  • R&D, Technology Transfer, QC / Microbiology laboratory personnel
  • Those involved in clinical trials, regulatory affairs, and manufacture, testing and oversight of microbial aspects of Investigational Medicinal Products will also find the course very useful
  • The course will be of particular value to small “virtual” start-up companies manufacturing and testing their product at CDMOs – contract manufacture and / or contract microbiology testing.  In the absence of a microbiologist in the company, the course will allow understanding of the risks which need to be managed

מה אקבל מכך בפועל?

Participants will come away able to develop a systematic microbial control strategy tailored to their process.

The strategy

  • Is tied in to and an extension of risk assessment/ control / management
  • Considers the process(es) and product(s)

מי מעביר את הקורס?

קרן גינסבורי
קרן גינסבורי, M. Sc. B. Pharm. MR PharmS – בעלת
קרא עוד

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