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SHORT COURSE 7: TECHNICAL DILIGENCE FOR IMPLEMENTATION OF SINGLE-USE SYSTEMS – QbD AND VERIFICATION OF TECHNICAL CAPABILITY AND SUITABILITY FOR PURPOSE  

 

Sunday, January 12 | 5:00-8:00 pm

The course will focus on Technical Diligence as part of a QbD-inspired implementation process for Single-Use Systems (SUS) as defined by the PDA Technical Report on SUS. For SUS, raw materials can be defined as an individual component, hybrid subsystem or a complete system forming part of the SUS. These should be evaluated for criticity. Nearly all SUS in direct impact can be considered as having a Critical status meaning that the suppliers require particular attention regards their technical capabilities in terms of product and process understanding and characterization (manufacturing process, monitoring, supply chain and storage). Building on established principles, Technical Diligence is the means by which the technical capabilities of the SUS, the raw materials, its supplier and its fit with the end user are verified. It is applied as the first step in a quality audit programme and becomes a recurring theme over the implementation process and subsequent routine procurement.

The topics to be covered:

  • Technical Diligence implies documented visits to the supplier(s)/vendor(s) 
  • The outcome - an appropriate and measured understanding of all the technical issues concerned with the SUS, its manufacture and end-user fit 
  • Key points to address:
    • Supplier, its integration and supply chain 
    • SUS product manufacturing (construction and integration) 
    • SUS quality 
    • End-user compatibility (fit) 
     

 

Instructor:

Stephen W. Brown, Ph.D., CTO and Executive Director, Technical Development, Clinical Manufacturing Unit, Nantes, BE Vaccines SAS

Speaker Biography

Stephen Brown Ph.D.Stephen W. Brown, Ph.D., CTO and Executive Director, Technical Development, Clinical Manufacturing Unit, Nantes, BE Vaccines SAS 

Stephen Brown is co-manager of BE Vaccines SAS, the Clinical Manufacturing Unit (CMU) and centre of excellence for viral vaccine development, based in Nantes, Western France (formerly Valneva and Vivalis). The CMU is part of the Technical Development organization within Biological E. Limited, a biotechnology company based in Hyderabad, India. Steve has worked in the biopharmaceutical industry for 32 years, focusing on the manufacture of IMPs - live viral vaccines, gene and cell-based therapies and the production of recombinant therapeutic proteins. He has wide technical experience in the GMP domain and has designed, constructed and implemented several GMP development facilities. Steve is a member of the PDA Single-Use Systems Task Force currently preparing a Technical Report on disposable manufacturing solutions (Steve is the lead for Chapter 7 - Implementation); founder of the Gene and Cell-Based Therapies Task Force and was a member of PDA's Biotechnology Advisory Board 2010-12. Stephen Brown has presented in different training courses, for PDA (Dedicated Facilities and Single-Use Systems), PDA-PICS (ICH Q7A) in Beijing, the Institute Pasteur Paris Vaccinology Course (GMP) and participates in the Biopractis GMP Training Centre in Nantes (GMP).

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