Stability Studies in the development and production of drugs

  • 5 e 12 April 2024
  • Online
  • Italian

Training overview

Module 1: 5 April 2024 – Regulatory aspects and minimal requirements for a stability study

The training course “Stability Studies in Pharmaceutical Development and Manufacturing” aims to illustrate the criteria according to which to plan stability studies for API and/or finished product throughout the drug lifecycle, from the initial stage of development, through to commercialization. The main points related to stability studies will be covered: when they are required and for what purposes, what is required by regulations, what is the structure of a study that meets the minimum requirements in relation to the climatic zones of application, and how to interpret the data obtained.

Module 2: 12 April 2024 – ICH and EMA guidelines supporting stability studies

In this second module of the training course “Stability Studies in Pharmaceutical Development and Manufacturing”, having already covered the contents of the main guideline for ICH Q1A(R2) stabilities in module 1, the other ICH guidelines belonging to the Q1 group, which are important support tools for optimizing activities, will be addressed in detail, accompanied by practical examples from the lecturer’s experience. The aspects of API and finished product stability before packaging (holding time studies), as well as the stability of multidose finished products and/or reconstituted solutions (stability in use) will then be addressed. Finally, the minimum requirements for stability studies in the case of changes on AICs will be examined.

If you participate in both modules the price is 900 €!

Key points of the training

  • Understand the purpose and scope of stability studies on API and finished product
  • Learn which are the regulatory requirements
  • Understand how to ensure that the stability program meets global market demands
  • Acquire the criteria for developing a comprehensive and compliant stability plan
  • Understand how to interpret data for shelf-life prediction
  • How to apply the ICH guidelines of the Q1 group
  • Principles of bracketing and matrixing: application criteria and examples
  • How to plan a stability study for multidose products (stability in use)
  • How to define storage criteria for APIs and formulated products before packaging (holding time)
  • How and when to activate a stability study in the case of changes in A.M.

MODULO 1: 5 April 2024
09:00 – 13:00 COURSE SESSION

Introduction

  • Definition and purpose of stability studies
  • Specific definitions and terminology

Types and purpose of stability studies

  • Types of stability at various stages of the lifecycle
  • GMP requirements: guidance and references

Regulatory requirements

  • Requirements and guidance from ICH Q1
  • Requirements and guidance from EMA guidelines
  • Requirements and guidance from WHO and Asian guidelines for climate zones III and IV

ICH Q1A(R2): structure of the study

  • Scope of the guideline
  • Operating conditions (temperature, humidity, duration)
  • Numerosity of controls
  • Evaluation of experimental stability data for shelf life prediction

Discussion and questions

Test with correction

 

MODULO 2: 12 April 2024
09:00 – 13:00 COURSE SESSION

The ICH Q1 guidelines

  • Q1B: The photo stability studies
  • Q1C: New dosage forms, definition and requirements
  • Q1D: Matrixing & Bracketing
  • Q1E: stability data evaluation

EMA guidelines: in-use stability studies

  • Stability of reconstituted solutions
  • Stability of products in multidose packaging

Stability of APIs and formulated products before packaging: definition of holding times

Requirements for Marketing Authorization variations

Discussion and questions

Test with correction

Quality Control, Quality Assurance, Validation team, Chemical and formulation development, Production, Regulatory Affairs.

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

Susanna Del Ciotto

Senior GMP Consultant., Quality Manager, Project Management

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
810€
900€
Early Bird 5%
Within 1 month before the start of the training
855€
900€
Full price

900€

Training materials available for attendees

Certificate of attendance

Senior trainers with hands-on experience

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