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Pharma & Biotech Stability Testing
Pharma & Biotech

Pharma & Biotech Stability Testing

Date to be announced

Contact us for more info
Price available after dates are announced

TRAINING TIMES

  • TBDVienna
  • TBDLondon
  • TBDNew York
  • TBDLos Angeles
Online Training



LEARNING OBJECTIVES

Learning Objective

Key degradation mechanisms for drugs and biologics

Key degradation mechanisms for drugs and biologics

Learning Objective

Protocol design, including bracketing and matrixing

Protocol design, including bracketing and matrixing

Learning Objective

Establishing the suitability of analytical methods

Establishing the suitability of analytical methods

Learning Objective

Considerations for global registration

Considerations for global registration

Learning Objective

Justifying impurity limits

Justifying impurity limits

Learning Objective

Handling temperature/humidity excursions and anomalous results

Handling temperature/humidity excursions and anomalous results

Learning Objective

Designing stability studies to support post-approval change

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

TRAINER

Dr Mark Powell

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.

Learn More →