Validation of Analytical Methods according to ICH Q2

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.