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Thought-Provoking Sessions You Don’t Want to Miss at the Aseptic Processing Technology Conference!

Keynote Sessions:

Andrew Hopkins - Keynote Speaker for 2016 Aseptic Processing Technology ConferenceNewly Confirmed Speaker: Andrew Hopkins – Tuesday, 1 March
Aseptic Processing: A European Regulator’s Perspective
Learn from Andrew Hopkins, Expert GMDP Inspector, MHRA as he provides insight on Annex 1 from a European regulatory perspective. You’ll gain knowledge on the history of Annex 1, the revision process, why it’s being updated, and its current status.

 

Joan Byrne - Keynote Speaker for 2016 Aseptic Processing Technology ConferenceJoan Byrne – Monday, 29 February
25 Years in Aseptic Processing: A Continuous Improvement Journey

Joan Byrne, Vice President of Biologics and Combination Products, AbbVie Quality Assurance will review current challenges in critical product understanding. You’ll explore complex formulation requirements and learn about crucial supplier and TPM partnerships.

 

Topics of Special Interest:

Industry Panel Discussion: Focus on Robotics
Monday, 29 February
Moderator: Josh Russell, Product Manager – Life Sciences, AST

Interact with the opinion leaders of AST, BOSCH, B+S, VanRX, Groninger, Vetter, Inova and Fedegari as they provide insights on the latest challenges being faced while employing current technologies in domestic and international markets.

ISPE Baseline® Guide Update: Sterile Product Manufacturing Facilities
Tuesday, 1 March 2016

  • Introduction/Overview: Jason Collins, IPS
  • Classification Harmonization: Norm Goldschmidt, Genesis
  • Architectural Layouts & Finishes: Jason Collins, IPS
  • Barrier and Isolator Technology: Thomas Huber, SKAN
  • Q&A

Regulatory Panel Discussion
Tuesday, 1 March 2016

Be a part of this year’s dynamic discussion surrounding the aseptic industry.
Panelists include:

  • David Doleski, Deputy Director (Acting), FDA/CDER/OPQ/OF, USA
  • Lynne Ensor, PhD, Division Director (Acting), FDA/CDER/OPQ/OF/DMA, USA
  • Richard Friedman, Deputy Director, Science and Regulatory Policy, FDA/CDER/OC/OMQ, USA
  • Andrew Hopkins, Expert GMPD Inspector, MHRA
  • Robert Sausville, Director, Division Case Management, DA/CBER/OMPT/OCBQ, USA

Register for the must-attend conference of 2016 – Aseptic Processing Technology Conference!

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