Press release
The Latest Techniques in HPAPI Facility Design
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 O’Connell, 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 http://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
Conference organisers
SMi Group Ltd
India House, 35 Curlew Street
London
SE1 2ND
United Kingdom
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