חדש

דרישות האיכות החדשות והמחייבות של ה ICH לתכשירים רפואייםNEW – Analytical Methods development ICH Q14
REVISED – Methods Validation ICH Q2 R1
Review all the ICH Quality Guidances

בהדרכת: גב' קרן גינסבורי
גרסה להדפסה

שתף קולגה:

Do you work in analytical R&D developing methods? Do you perform methods transfer? Methods qualification? Methods validation?

Did you know ICH Q2 R1 Methods Validation has been issued after major revision? ICH Q14 Analytical Methods development has been issued at step four – for implementation world-wide. Are your ready for the new paradigm?

המשך קריאה

Do you work in analytical R&D developing methods?
Do you perform methods transfer? Methods qualification? Methods validation?

Did you know ICH Q2 R1 Methods Validation has been issued after major revision?
ICH Q14 Analytical Methods development has been issued at step four – for implementation world-wide.
Are your ready for the new paradigm?

These are global guidances and you can expect ever inspector to review your analytical methods for compliance… at the very least for any method issued / transferred / validated after November 2023

This course will review ICH as part of the worldwide regulatory framework.
All the current guides will be reviewed at the level of table of contents and relevance.
Revised ICH 2 and newly issued Q14 will be reviewed in detail.

סגור
תאריך:  19 מרץ, 2024

מתעניינים? לחצו כאן

    מיקום הקורס: המיקום יפורסם בקרוב
    משך הפעילות: יום עיון
    שעות: 17:00 - 09:00
    נקודות זכות: 1
    שפת הקורס: עברית

    עלות הקורס המלאה: ₪2,300 + מע"מ
    יש לך מנוי? מגיעה לך הנחה נוספת!

    יש לך שאלה? יש לנו את כל התשובות

    מה תכני הקורס?

    Review of ICH as an organisation:

    • Objectives of ICH
    • Regulatory standing of the organisation
    • Overview of their methodology:
      E/Q/S/M modules

    Review of the Quality Guidelines

    • Q1 Stability Testing
    • Q2 Analytical Methods Validation
    • Q3 Impurities
    • Q4 Pharmacopeial harmonization
    • Q5 Viral Safety Evaluation – Biotech Products
    • Q6 Specifications: Test Procedures and Acceptance Criteria
    • Q7 GMPs for Active Pharmaceutical Ingredients
    • Q8 Pharmaceutical Development
    • Q9 Risk Management
    • Q10 Pharmaceutical Quality System
    • Q11 Development and Manufacture of Drug Substance
    • Q12 Lifecycle Management of Products
    • Q13 Continuous Manufacturing
    • Q14 Analytical Methods Development

    למי זה מתאים?

    The course is suitable for anyone involved in R&D, contract laboratory services (provider or user) quality control, quality assurance, regulatory affairs, and any other discipline that interfaces with manufacturing and control of pharmaceutical development or production.

    מה אקבל מכך בפועל?

    At the end of this course participants will have increased their awareness of ICH as a critical standard setting organisation in the regulatory world. The course will provide the opportunity to refresh and renew knowledge of ICH's critical quality guidelines especially as they relate to methods development, transfer, qualification and validation.

    מי מעביר את הקורס?

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

    הוספת תגובה

      אנא חזרו אלי