PDA Workshop on Cleanroom Technology and Contamination Control


Dear BFS member

I am pleased to tell you that the Parenteral Drug Association (PDA) will be hosting a workshop on cleanroom technology and contamination control on April 19 in Las Vegas, Nevada. The PDA Workshop: Cleanroom Technology and Contamination Control will immediately precede the 2009 PDA Annual Meeting.

FDA representatives (invited) and industry colleagues will lead conference presentations. The program will examine how to reach compliance with both US and EU requirements in these areas and feature five sessions that will provide you with the most current information regarding compliance challenges for current and regulatory requirements; validation strategies and risk management as related to regulatory requirements; how to achieve a safe cleanroom environment through proper design or processes; and much more.

In addition, one entire session will be dedicated to the topic of blow-fill-seal practices. This session will examine a best practices technical report for pharmaceutical blow-fill-seal manufacturing operations - prepared by PDA and the Pharmaceutical Blow-Fill-Seal International Association (BFSIOA). Session speakers will also examine the comments received during PDA's global review of the draft document.

Tor Graberg, Chief Pharmaceutical Inspector, MPA, PICS; Daniel Osterby, Director of Technical Operations, Catalent PharmaSolutions and Ken Muhvich, Principal consultant, Micro-Reliance will lead the discussions in this session. You don't want to miss this chance to learn discuss and influence this document before it's published!

Other confirmed speakers include:

  • James Akers, PhD, President, Akers, Kennedy and Associates
  • Leslie Edwards, CEO, Isogen, LLC
  • Ruth Kane, Director, Audit and Assessment, AstraZeneca
  • Stefan Köhler, Director, AstraZeneca AB
  • Bengt Ljungqvist, PhD, Professor, Royal Institute of Technology
  • Johannes Rauschnabel, Director, Process Engineering, Robert Bosch GmbH Packaging Technology Pharma
  • Berit Reinmuller, PhD, Senior Researcher, Royal Institute of Technology
  • Stefan Sundström, Senior Engineer, AstraZeneca

PDA will give a special offer to members of the BFS IOA: 10% off for the workshop registration price; discount price = $560.00. You will also get a discount off for the current Annual meeting price $1650.00 instead of $1850.00. Please not that these prices will not apply for on-site registrations.

You can save $50 when you register for this workshop in addition to the 2009 PDA Annual Meeting. Or, you can save $100 when you register for this workshop, the 2009 PDA Annual Meeting and the Cleanroom Management course.

All registrations should be sent by fax directly to Patresa Day at PDA.

For more information, visit www.pda.org/cleanroom. I hope to see you in Las Vegas in April.


Peter Åkerman, AstraZeneca,

Chairman of the Board BFS IOA
Member of the Program Planning Committee, PDA Workshop: Cleanroom Technology and Contamination Control