Pharma & Biotech Stability Testing

    Pharma & Biotech Stability Testing

    Dates TBC, live online training

    Summary

    Stability data form an important element of pharmaceutical regulatory submissions. This 3-day course will equip participants with the necessary knowledge to design and conduct stability studies that meet regulatory requirements. The course covers stability evaluations performed throughout the drug product life cycle, from product development to post-approval changes. Topics include fundamental chemical concepts, protocol design and the appropriateness of test methods for stability studies. The specific challenges posed by biological molecule stability are also covered. Each day includes a workshop session designed to reinforce key learning points.

    Learning Objectives

    • Key degradation mechanisms for drugs and biologics
    • Protocol design, including bracketing and matrixing
    • Establishing the suitability of analytical methods
    • Considerations for global registration
    • Justifying impurity limits
    • Handling temperature/humidity excursions and anomalous results
    • Designing stability studies to support post-approval change

    Key Topics

    • Drug degradation chemistry
    • Regulatory guidance
    • Registration in different climatic zones
    • Stability chamber management
    • Design and validation of test procedures
    • Trending stability data – managing out-of-specification/out-of-trend results
    • Data integrity
    • Predictive stability
    • Stability testing for biologics
    • Impact of leachables on drug product stability

    Who should attend?

    Formulation Development Scientists, Process Development Personnel, Analytical Development Scientists, Quality Control Personnel, Stability Study Managers, Regulatory Affairs Specialists, Project Managers

    Our online training experience includes

    • Our client zone – a single source for all training materials as well as pre and post-training communication
    • Live interactive format via the Zoom platform
    • Direct interaction with the trainer
    • Q&As, case studies, polls
    • Revisit recorded sessions for 30 days
    • Training in digital format
    • Digital and LinkedIn certificates

    Trainer

    Dr Mark Powell
    Dr Mark Powell a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as a senior analytical chemist. Mark has served as both Honorary Secretary and Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016.

    Pharma & Biotech Stability Testing

    Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

    PC, microphone, camera, stable internet connection and the Zoom application.

    Yes, we will make every effort to ensure best possible interaction. You will see the slides, interact with the trainer and fellow participants. Questions and group exercises will be facilitated through the online meeting platform.

    Yes, you can transfer the registration to a colleague at any time.

    Yes, you may transfer your registration to a different event up to one month before the scheduled dates, provided the training fee has been paid in full.

    pharma learning leader

    Lydia Makori

    l.makori@symmetric.events
    +421 222 200 543

    Training Details
    What participants said about this course

    "Great course overall, Mark was easy to listen to, with humour and extensive knowledge."
    Quality Manager, Cambrex

    "I found this course very insightful and knowledgeable as I am relatively new to my role as a stability coordiantor. The materials I have learned in throughout this course will be very beneficial to me."
    Stability Coordinator, Chanelle Pharmaceuticals

    Training Material Preview