Pharma & Biotech

Pharma & Biotech Stability Testing

Date to be announced

Price available after dates are announced

TRAINING TIMES

TBDVienna
TBDLondon
TBDNew York
TBDLos Angeles

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

TRAINER

Dr Mark Powell

Mark Powell Scientific Limited, UK, Director

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. He has worked at a senior level in several 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, and stability/stress studies.

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