Module 2: 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.
Module 1: 24 October 2023 – Regulatory aspects and minimal requirements for a stability study
If you participate in both modules the price is 850 €!
Key points of the training
- 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.
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
Module 2 is suitable for professionals involved in the definition/management of stability studies within the Quality Control, Quality Assurance, Validation team, Chemical and formulation development departments.
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 firstname.lastname@example.org 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 email@example.com. 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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