Update for SMi’s Highly Potent Active Pharmaceutical Ingredients Conference.
Key Sessions include:
Panel Discussion:
Control matrices, control algorithms, containment guides and confidence
– Importance of control matrices and algorithms
– Current status of containment guides
– Methods of optimising confidence towards worker safety
– Future of containment designs
Mr Peter Marshall, Associate Engineering Director, AstraZeneca
Mr Nigel Saunders, Technical Engineer – SME Containment, GSK
Dr Thomas Adam, Head of Global Quality Assurance Chemical APIs, Bayer
Internal procedure guide in handling high potent compounds
– Bayer quality organisation guidelines
– Internal procedures to minimise the risk of handling HPAPIs to workers
– Deciding the correct control based on a correctly identified hazard
Dr Thomas Adam, Head of Global Quality Assurance Chemical APIs, Bayer
Development and manufacture of HPAPI products through the clinical phases from molecule to market
– How HPAPIs can be developed into suitable drug dosage forms
– Strategies to adhere to the highest quality standards
– Complexities at each stage of the development cycle from FiM studies to global supply
Mr David OConnell, Director Scientific Affairs, PCI Pharma Services
Deep Dive Case Study
Risk assessment of highly potent APIs cross-contamination and transportation parameters
– Guidelines regarding quality risk management
– Case study 1: technical aspects and complexity in cross contamination risk analysis
– Case study 2: temperature deviation during transportation
Dr Ildikó Ziegler, Distinguished Validation Expert, Gedeon Richter
Design and innovation of a new compound facility
– Reconstruction guidelines for adapting existing facilities to meet the needs of HPAPIs
– Ensuring facility reconstruction meets GMPs
– Additional assets required for HPAPI adaptation
– Designing controls and training to address worker safety
Dr Jack Brown, Senior Principal Scientist, Boehringer Ingelheim
View the programme at www.highlypotentapi.com
Registrations made before or on January 31st will include a £400 discount of the standard price.
Conference: 13th and 14th May 2019
Post-conference workshop: 15th May 2019
Holiday Inn Kensington Forum, London, UK
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