Management of Elemental Impurities (ICH Q3D)

  • 1° EDITION: 13 December 2024
  • 2° EDITION: 16 May 2025
  • Online
  • Italian

Training overview

The training aims to complete the information acquired within the scope of the course related to Section 3 of the CTD regarding the management of Elemental Impurities, metallic contaminants whose content must be limited and controlled in medicinal products.
Specifically, the objective is to outline the regulatory requirements included in the dedicated guideline ICH Q3D, for which Revision 2 has recently been implemented, and to provide support for the development and implementation of appropriate assessment and control techniques.

Key points of the training

  • The regulatory requirements related to elemental impurities
  • Criteria for Establishing the Acceptable Exposure Limit (PDE)
  • Which EI should be monitored
  • Possible control strategies applicable to elemental impurities
Course Structure

9:00 – 13:00

  • Introduction:
  • Course Objectives
  • Background
  • Introduction to the ICH Q3D Guideline: History and Revisions
  • Criteria for Establishing PDE Limits
  • Classification of Elements
  • Risk Assessment as the Basis for Defining Control Measures
  • Definition of Elemental Impurity Sources
  • Identification of Potentially Present Elemental Impurities
  • Preparation of Risk Assessment 
  • Control of EIs and Methods of Limit Expression Management of EIs in the Product Lifecycle Examples or Group Practical Exercises

Il corso è rivolto a Controllo Qualità, Assicurazione Qualità, Affari Regolatori.

The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.

For online trainings the access link will be sent 2-3 days before the start of the training.

5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.

Cancellation terms

In order to cancel enrolment to an event, please email within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.

Participant replacement

It is possible to replace a participant attendance without additional cost, simply by contacting It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.

Training cancellation

If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.


Susanna Del Ciotto

Susanna Del Ciotto

GMP trainer and auditor

Graduated in Chemistry from the University of Parma, she has been working in the pharmaceutical sector for about 20 years. She has held various roles of responsibility in the QC sector, such as Laboratory Manager for Stability Studies, Analytical Method Development and Validation, Chemical Laboratory for Pharmaceutical Control, and finally as QC Manager. Currently, she works as a trainer and consultant, focusing on GMP compliance, non-conformity resolution, laboratory investigations, and the preparation and conduct of audits, with particular emphasis on managing inspections by regulatory authorities such as AIFA and FDA.

Register now

Early Bird 10%
Within 2 months before the start of the training
Early Bird 5%
Within 1 month before the start of the training
Full price


Training materials available for attendees

Certificate of attendance

Senior trainers with hands-on experience

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