New

NEW – Analytical Methods development ICH Q14 REVISED – Methods Validation ICH Q2 R1 AND review all the ICH Quality Guidances

Conducted by: Ms. Karen Ginsbury
Print version

Share a colleague:

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...Continue reading

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.

Close
Date:  19 March, 2024

מתעניינים? לחצו כאן

    Course location: Hybrid: Kfar Maccabiah, Ramat Gan or ZOOM
    Duration: One Day Course
    Hours: 09:00 - 17:00
    Credits: 1
    Course Language: עברית

    Course price: ₪2,300 + VAT
    Do you have a subscription? You deserve more

    Have a question? We got all the answers

    Issues to be covered

    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

    Who should attend

    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.

    Benefits to the Participants

    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.

    About The Lecturer

    Karen Ginsbury
    B.Pharm, M.Sc, MRPharmS, has over twenty five years of experience
    Read more
    תחזוקת מערכת האיכות בזמן מלחמה QMS

    Leave a Reply



      [anr_nocaptcha g-recaptcha-response]