Pharma & Biotech

Specifications for Small Molecule Drug Products

Date to be announced

Price available after dates are announced

TRAINING TIMES

TBDVienna
TBDLondon
TBDNew York
TBDLos Angeles

LEARNING OBJECTIVES

Current regulatory expectations

How to set meaningful specifications for raw materials and drug products

Using the principles of quality risk management for impurity control

Avoiding common errors and omissions

KEY TOPICS

Regulatory guidance Specifications (ICH Q6A) Impurities (ICH Q3 family of guidance documents) Genotoxic impurities (ICH M7)

Specifications (ICH Q6A)

Impurities (ICH Q3 family of guidance documents)

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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