2013 Flexible Facilities EU Conference2013 Flexible Facilities EU Conference2013 Flexible Facilities EU Conference
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Education Details

View the Conference Agenda ( 157 KB)

View the Conference Flyer ( 694 KB)

View the Invitation from Co-chair Robert J E Bowen ( 140 KB)

Conference Programme Committee

Honorary Chair: Gert Mølgaard, Vice President (VP), Strategy Development, NNE Pharmaplan, Past Chair for ISPE  

Chair: Thomas Zimmer, Former SVP EHS & Sustainability of Boehringer Ingelheim, CEO of ZS.CTIS Consulting GmbH

Co-chair: Robert J E Bowen, Director, Facilities Integration Ltd; Global Co-Chair, ISPE Sustainable Facilities COP

Operations Track Leader: Chris Mullen, Head of Operations, Fujifilm Diosynth Biotechnologies

Facilities and Plants Track Leader: Jean-François Duliere, Pharmaceutical Process Technologist, Technip Life Sciences

IT and Automation Track Leader: Chris Reid, Director, Integrity Solutions Ltd

Stephanie Wilkins, Consultant, PharmaConsult US

Bruce Williams, Director, Williams Process Limited

Bryan Wright, European Regulatory Affairs Advisor, ISPE

 

Keynote Speakers

Andreas Flueckiger, Chief Occupational Health Officer, F. Hoffmann-La Roche Ltd, Switzerland

Dr. Lou Schmukler, President, Global Manufacturing & Supply, Bristol-Myers Squibb Company

Dr. Gabriele Schoenberger, Director, Boehringer-Ingelheim GmbH

Conference Tracks 

Track 1: Operations

Track Leader: Chris Mullen, Head of Operations, Fujifilm Diosynth Biotechnologies

This track will explore topics related to manufacturing operations, and how to safely and compliantly introduce new products. Know when and how to use shared facilities and understand the impact of changing regulations on your operations. Discuss effective ways to manage the risks that flexibility brings and avoid human errors, which are no longer accepted as root causes of quality issues. Learn how flexible facilities can increase agility to respond to market needs when supported by robust, compliant and sustainable business processes.

Gain a deeper understanding of:

  • Health-based exposure limits, and how ISPE Risk MaPP can help you meet changing EU GMPs
  • The impact of flexibility on your business – from Supply Chain to Engineering and Maintenance to Quality Control and Quality Assurance
  • How disposables have moved beyond biotech APIs to provide high-productivity, cost-effective sterile filling lines for a rapidly changing product portfolio

Track 2: Facilities and Plants

Track Leader: Jean-François Duliere, Pharmaceutical Process Technologist, Technip Life Sciences

Improve your knowledge of the requirements of factory and process design in the pharmaceutical industry. Topics covered include human-centred design, standardised modular plants and portable equipment, as well as the pros and cons of both single-use and stainless steel products.

Learn about:

  • The challenges that regulatory requirements place on plant and facility design, and how to design and size equipment to implement lean production
  • Sustainability and resource efficiency of the flexible facility
  • How health-based residue limits affect facility design

Track 3: IT and Automation

Track Leader: Chris Reid, Director, Integrity Solutions Ltd

IT and Automation tools are a key asset in flexible, agile facilities. This track highlights the requirements for operating a flexible and multi-purpose facility and managing data and automation; and also explores the use of IT applications to meet required safety and environmental standards. It includes a discussion of new technological developments including virtual collaboration, wireless technology and modelling and simulation tools.

Gain knowledge on:

  • Evaluating process and functional risks while maintaining compliance with a flexible operation
  • Managing the move from parametrics to attribute approach and exploring the options for process analytical applications (PAT) in flexible manufacturing
  • Effective Enterprise Resource Planning and Manufacturing Execution within a flexible process environment

Must-Attend Workshop Session!

The object of the session is to bring pharmaceutical industry together in high level interactive workshop discussion to address a selection of issues related to innovative equipment installation in flexible/shared pharmaceutical manufacturing. The workshop offers the opportunity to represent the technology utilised by your company during a dedicated education session, combined with a physical demonstration of the presented equipment.

View the Conference Agenda ( 157 KB)

Networking Evening

Social Networking Drinks and Dinner:  Monday 30 September 2013, 17.30 - 21.00
ISPE invites you to attend complimentary networking drinks on the evening of Monday 30 September. 
A three-course dinner will follow at the restaurant La Manufacture at 19.30. Transport to and from La Manufacture will be provided to participants to the networking dinner. 

Participants to the dinner will be charged €60 per person (VAT not included). Register now!

Thank you to our Top Tier Sponsors

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