This workshop will provide participants with a comprehensive understanding of analytical testing according to ICH Q1A (R2), laboratory logistics strategies and a technical insight for all things Storage and Stability testing.
Stability studies aim to ensure a product's long-term integrity, efficacy, quality, and patient safety. Regulatory authorities are becoming more vigilant; for example, the FDA issued over 260 warning letters and recalled more than 700 products between 2012 and 2023. It is therefore essential to put in place an optimal program, both for patient safety and for the interests of the manufacturer. We invite you to learn more from our experts during our workshop!
Topics:
1. Comprehensive Guide to Stability Testing According to ICH Q1A (R2)
2. Mastering Stability Storage and Logistics: Proven Strategies for Reliable Results
3. Technical Insights into Method Development for Stability Testing
4. Photostability, Transport Stress, and In-Use Evaluations of Pharmaceutical Products
5. Exploitation of Stability Data
Speakers:
SYLVAIN DARONDEL
Sylvain Darondel is our Business Unit Manager for Storage &
Logistics at Eurofins BioPharma Product Testing France and
is also an engineer by training, who participated in the
creation and development of our storage and logistics
activities under GMP conditions over 20 years ago. He has
also developed expertise in the fields of storage in standard
conditions (ICH, MDR) and specific conditions (cycling, cold)
and logistics in controlled conditions for health products.
ALISSA ESTEVEZ
Alissa Estevez is our Team Leader Sample Testing at
Eurofins Biopharma Product Testing Fontenilles, France.
Alissa’s team are experts in QC analyses (Ph. Eur, USP,
Chinese & Indian) and stability analyses (long-term,
photostability, in-use, stress, etc). Alissa’s experience in
cosmetics and industrial lubricants allowed knowledge of
chemistry in various fields, which led her to join Eurofins 7
years ago as a project manager on stability studies.
KRISTINA GROETZINGER
Kristina Groetzinger is our QC Manager at Eurofins
BioPharma Product Testing Germany focusing on the
verifications and validations of a wide variety of methods
being essential for analytical examination of quality and
stability of pharmaceutical products, base materials,
excipients, and APIs alike. She is a biochemist with a Ph.D.
in phytoanalytical research including HPLC method
development, isolation and structure elucidation of naturally
occurring active compounds in medicinal plants.
APPLICABLE FEE – €195 Excl VAT*
WORKSHOP LANGUAGE: ENGLISH
FEE INCLUDES: DOCUMENTATION, LUNCH AND REFRESHMENT.
You'll receive confirmation, payment, and invoicing details via e-mail after submission.
GENERAL TERMS AND CONDITIONS:
IF YOU CANNOT ATTEND THE WORKSHOP YOU HAVE TWO OPTIONS:
1. WE ARE HAPPY TO WELCOME A SUBSTITUTE COLLEAGUE AT ANY TIME.
2. IF YOU HAVE TO CANCEL ENTIRELY WE MUST CHARGE THE FOLLOWING
PROCESSING FEES:
BEFORE 1 WEEK PRIOR TO THE WORKSHOP 50% OF THE REGISTRATION FEE WILL BE CHARGED;
LESS THAN 1 WEEK PRIOR TO THE WORKSHOP FULL REGISTRATION FEE WILL BE CHARGED.
EUROFINS MEDICAL DEVICE RESERVES THE RIGHT TO CANCEL OR ALTER THE PROGRAMME, THE SPEAKERS, THE DATE OR VENUE.
IF THE EVENT MUST BE CANCELLED, REGISTRANTS WILL BE NOTIFIED AS SOON AS POSSIBLE AND WILL RECEIVE A FULL REFUND
OF FEES PAID. EUROFINS MEDICAL DEVICE IS NOT RESPONSIBLE FOR AIRFARE, HOTEL OR OTHER COSTS INCURRED BY REGISTERED DELEGATES.
TERMS OF PAYMENT:
IMPORTANT: THIS IS A BINDING REGISTRATION AND ABOVE FEES ARE DUE IN CASE OF CANCELLATION OR NON-APPEARANCE. IF YOU CANNOT TAKE PART, YOU HAVE TO INFORM US IN WRITING. THE CANCELLATION FEE WILL THEN BE CALCULATED ACCORDING TO THE POINT OF TIME AT WHICH WE RECEIVE YOUR MESSAGE. ONLY AFTER WE HAVE RECEIVED YOUR PAYMENT, YOU ARE ENTITLED TO ATTEND THE WORKSHOP.