Environmental Monitoring in the Pharmaceutical Sector

  • 2° EDITION: 24 May 2024
  • Online
  • Italian

Training overview

Analytical validation, according to the criteria described in the ICH Q2 guideline, has been applied in the pharmaceutical industry for many years but it is not always clear how to verify validation characteristics and how analytical validation results are statistically processed/interpreted. The purpose of the training “Validation of Analytical Methods according to ICH Q2” is to provide the necessary tools and basics for those tasked with performing analytical validation. The course therefore focuses on the interpretation of the ICH Q2 guideline by examining the main features of validation, recalling the most traditionally used statistical methodologies and defining the applicable acceptance criteria. All with a series of practical examples.

Would you like to participate, but you’re not available on this date?
The course will be provided again:

  • November 11th 2024
  • May 26th 2025

(*) Contact us via email or phone to enroll.

Key points of the training

  • The regulatory requirements related to Environmental Monitoring
  • The sampling methods and techniques, and how to validate them
  • Perform microbiological and particulate validation of environments
  • Learn how to perform transfer of an analytical method to another laboratory
  • Learn what points to consider in a validation experimental design
Struttura del corso

09:30 – 12:30 MORNING SESSION


  • Aims of the course
  • Validation method of analysis: definition
  • Guidelines and normative references: Overview
  • Hints at the main general USP chapters (1224, 1225, 1226)
  • Hints at the contents of existing guidelines


  • Validation pre-requisites
  • Types of methods and validation to be applied
  • Validation documentation

ICH Q2A(R1): Experimental design of validation

Additional FDA guidance

Validation vs. verification of compendial methods

Transfer of an analytical method

  • Types of analytical transfer
  • Experimental design by transfer type

Hints of statistics for similarity assessment

Personnel involved in the pharmaceutical sector: in the analytical field and in Quality Assurance and Regulatory Affairs (personnel dealing with concepts and issues concerning Analytical Validation).

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 info@pharmaeducationcenter.it 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 info@pharmaeducationcenter.it. 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

She is graduated in Chemistry at the University of Parma and she has been working in the pharmaceutical sector for about 20 years. She held positions of responsibility in the QC sector as Head of the Laboratory for Stability Studies, Development and Validation of Analysis Methods, Chemical Laboratory for the control of MPs, and finally as QC Manager. She currently works as a trainer and consultant for GMP alignment, resolution of non-conformities, laboratory investigations, preparation and conduct of Audits with a particular focus on the management of inspections by the AIFA and FDA regulatory bodies.

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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