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Application of Quality Risk Management to Process Validation

Robert Dream, Managing Director, HDR Company LLC

A Holistic Phase Appropriate Strategy for HCP-Limits and HCP Characterization

Dr. Markus Haindl, Global Head Gene Therapy Technical Research & Development, Roche Di...

Strategies for Extractable and Leachable Risk Assessment of Polymeric Single Use Systems U...

Ping Wang, Director, Johnson & Johnson

Use of Non-Contact Raman Spectroscopy to Derive Reaction Kinetics

Richard Hart, Senior Director – Head of Automation and Data Science (Previously Asso...

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FDA places Bright Minds’ planned BMB-101 Phase II epilepsy study on partial clinical hold


Shockwave Javelin IVL catheter shows positive results in pivotal FORWARD CAD study


FDA grants Priority Review to uniQure’s Huntington’s disease gene therapy


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Past Webinars

Shortages of critical raw materials and managing changes and substitutions

Presented by Frances Sexton – TS/MS Bioprocess Chemist – Materials Management, Eli Lilly and Dennis Jenke, Chief Executive Scientist at Triad Scientific Solutions on Behalf of Nelson Labs
28th April 2022


Key components of a comprehensive program for the management of single use technologies in biologics manufacturing

Presented by John Maguire, Shire and Donald Young, ThermoFisher Scientific
18th July 2018


Mechanistic Modelling in Early Stage Chromatography Process Development for Improving Process Efficiency and Productivity

Presented by Yuyi Shen, Associate Director, Process Development and Manufacturing at Bolt Therapeutics and Nick Whitelock, Business Development Manager at GoSilico GmbH
19th April 2021


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