Validation of Analytical Methods according to ICH Q2
- 1° EDITION: 9 November 2023
- 2° EDITION: 10 June 2024
- Online
-
Italiano
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.
Key points of the training
- Learn what are the references and regulatory requirements for validating an analytical method
- Learn when validation is necessary and when verification of an analytical method is sufficient
- Decide which parameters to evaluate and according to which acceptability criteria
- 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
14:00 – 17:00 AFTERNOON SESSION
INTRODUCTION:
- 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
GENERAL CONCEPTS OF ANALYSIS METHOD VALIDATION
- 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.
Speakers
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
800€
Training materials available for attendees
Certificate of attendance
Senior trainers with hands-on experience
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