Module 1: 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: 27 October 2023 – ICH and EMA guidelines supporting stability studies
If you participate in both modules the price is 850 €!
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
09:00 – 13:00 COURSE SESSION
- 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
- 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.
In order to cancel enrolment to an event, please email email@example.com within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.
It is possible to replace a participant attendance without additional cost, simply by contacting firstname.lastname@example.org. 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.
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
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.
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