Quality by Design

-

Today more than ever regulatory guidance is increasingly focusing on the process robustness and product quality. The pharma world is also changing at an increasingly quickening pace. QbD philosophies must be quickly adapted for the development of any innovative products in order to ensure overall integrity.

QbD as a systematic approach enables products and process understanding and control, based on comprehensive science and quality risk management schemes. By understanding a product i.e. by formulation and processes in great detail, systematic approaches can be developed from an early stage to design quality into a product.

This year we will focus on how PAT plays a pivotal role in delivering the successful implementation of QbD validation. Practical case studies will be submitted associated with the potential pitfalls of practical applications, and how to avoid these hurdles. Practical approaches to QbD implementation in solid dosage forms and covering design as an end to end format.

2014 will see us focus on regulatory guidance from the FDA and MHRA and how we can deploy continuous process development - plant wide - into a previous operational plan.
Why attend this event:
• Employ QbD to design a formulation process. Harness raw material analysis and control strategy
• Utilize PAT tools and applications for pharmaceuticals, biopharmaceuticals and ATMPs
• Use risk assessment and management to best effect
• Accurately include QbD information in regulatory document filings, including those for ICH Q8 and ASTM E 2500
• Apply multivariate data analysis to maximize product development and patient outcomes
Key featured speakers:
• Julian Morris, Technical director, Centre for Process Analytics & Control Technology
• Andreas Schreiner, Head Validation Manufacturing Science & Technology, Novartis
• Marcel de Matas, Principal Scientist Formulation Science, AstraZeneca
• Frank Thielman, Operational Lead Inhalation New Solids, Novartis
• Martin Schubert, Head of Chemical Pharma Development, UCB
• Michel Ulmschneider, Senior Scientist, F Hoffman - La Roche A G
• Simeone Zomer, Technical Manager, GlaxoSmithKline
• Peter Boogaard, Director, Industrial Lab Automation

Plus an interactive half-day post-conference workshop: Successfully Implementing Quality by Design: An introductory Workshop QbD & PAT, hosted by Peter Boogaard, Founder, Industrial Lab Automation. Wednesday 26th February 2014, 9.00am – 13.00pm, Marriott Hotel Regents Park, London, UK.

For more information on the programme and speakers please click on the event website link or contact Ruth Christianson at +44 20 7827 6062 or email rchristianson@smi-online.co.uk


Location:
Marriott Hotel, Regents Park
128 King Henry's Road London, NW3 3ST United Kingdom
UK


Organizer: SMi Group Ltd

24 Feb 2014

Upcoming Featured Events
1 Next 
65th ASMS Conference4 Jun 2017
AACC 201730 Jul 2017


All Upcoming Events
1 2 Next 
65th ASMS Conference4 Jun 2017
Pre-Filled Syringes West Coast 20175 Jun 2017
The High Potent Medicines Conference6 Jun 2017
2nd Annual Bioprocessing of Advanced Cellular Therapies Congress8 Jun 2017
Pharmaceutical Microbiology USA8 Jun 2017
12th Annual ADMET 201712 Jun 2017
4th Annual Immunogenicity12 Jun 2017
In Vitro Diagnostics 201714 Jun 2017
Biobanking 201714 Jun 2017
2nd International Conference on Marine Drugs & Natural Products15 Jun 2017
HPLC 201718 Jun 2017
3rd International Conference and Expo on Biopharmaceutics and Biologic Drugs19 Jun 2017
Association for Environmental Studies and Sciences (AESS) 2017 Conference21 Jun 2017
International Conference on Environmental Chemistry and Engineering24 Jun 2017
13th International Conference and Exhibition on Pharmaceutical Nanotechnology24 Jun 2017
4th Annual Allergies6 Jul 2017
4th Peptides Event6 Jul 2017
13th International Conference on Materials Chemistry (MC13)10 Jul 2017
PREP 2017: 30th International Symposium and Exhibit on Preparative and Process Chromatography16 Jul 2017
3rd International Conference on Organic & Inorganic Chemistry17 Jul 2017
ISPPP 2017: 37th Symposium and Exhibit on the Separation and Characterization of Biologically Important Molecules19 Jul 2017
AACC 201730 Jul 2017
7th Global Experts Meeting on Neuropharmacology31 Jul 2017
3rd World Congress and Exhibition on Antibiotics and Antibiotic Resistance31 Jul 2017
Precision Medicine & Ion Channel Retreat 20179 Aug 2017
2nd International Conference on Generic Drugs and Biosimilars24 Aug 2017
14th International Conference and Exhibition on Pharmaceutical Formulations28 Aug 2017
13th Compound & Sample Management Summit28 Aug 2017
15th International Conference on Environmental Science and Technology (CEST 2017)31 Aug 2017
2nd European Prefilled Syringes Summit6 Sep 2017

Advertisement

Advertisement

Advertisement

Advertisement

Advertisement

Advertisement

Advertisement

Advertisement

Advertisement

Advertisement