Register now for our live webinar: Temperature Excursion and Cycling Studies with guest speaker Dr. Mark Powell.
Temperature Excursion and Cycling Studies
Temperature excursions during shipment can cause the recall of drug product lots, leading to delays in supply and loss of revenue. Data from a well-conducted temperature excursion and/or cycling study can be used to justify such excursions. There is currently no harmonised guidance dealing with the impact of temperature excursions during distribution or the effect of freeze/thaw cycles on liquids and semi-solids. This webinar reviews best practice in these areas.
This webinar will cover:
- Overview of regulatory guidance
- Temperature excursion risks to physical and chemical product stability
- Evaluating possible excursions using supply chain knowledge
- Temperature excursion studies
- Thermal cycling studies
- Transportation control strategy
About the speaker Dr. Mark Powell
Dr. Mark Powell is 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. He has worked at a senior level in a number of companies with responsibility for analytical development and equipment qualification. In 2010 Mark was appointed Scientific Manager of a UK-based pharmaceutical CRO, with responsibility for guiding the direction of drug development programmes as well as establishing collaborations with academia and instrument manufacturers.
In 2013, he set up his own company to provide training and consultancy services to the pharmaceutical industry. His consultancy work has involved, amongst other things, managing the analytical aspects of pharmaceutical development programmes and conducting data integrity audits. He is in demand as a trainer in topics such as pharmaceutical development, chromatography, spectroscopy, dissolution testing, data integrity, control of impurities, technical writing, stability/stress studies and sample preparation.
To register for this webinar today, please visit our webinar registration page.
Is there anything additional that you would like us to cover during this webinar? If you have any questions, please contact us and we will answer your question during the Q&A session at the end of the webinar.
Did you miss our other webinars? Recordings are now available online for our previous webinars:
- Biopharmaceutical Stability Studies: Stability is a particular problem for biopharmaceutical products because the physical and chemical stability of peptides and proteins are often very sensitive to storage and transportation conditions. The purpose of this webinar is to explain the typical approach for the design of a stability study for biologics. The webinar also covers the specific challenges of these product types as well as typical degradation mechanisms.
- Stability Study Design – Bracketing and Matrixing: Stability programmes are a costly undertaking, especially for products that have multiple strengths and packaging configurations, where a full study design will require every configuration to be evaluated for three registration batches at each time point. The use of reduced study designs such as bracketing and matrixing can reduce the cost of formal stability studies. This webinar describes when the use of such approaches is allowable, together with their associated benefits and risks.