Stability Studies in the development and production of drugs – Module 1

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

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.