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FDAers to Cover New Science and Tech at Annual

Mar 06, 2017

What do adventitious agent control strategies, virus detection technologies, and continuous biomanufacturing have in common? Well, for one, they represent areas of advancement within the pharma industry, and they are also topics that three US FDA regulators will discuss at the 2017 PDA Annual Meeting.

  • Patricia Hughes, PhD, Team Leader, Biotech Manufacturing, FDA, will present “Microbiological Control and Adventitious Agents” in session “A1 — Advances in Analytical Sciences & Quality Control Strategies,” Monday, April 3, 2:00 p.m.
  • Arifa Khan, PhD, Senior Investigator, CBER, FDA, will present “Virus Control, Safety, and New Technologies for Virus Detection,” in session “A1 — Advances in Analytical Sciences & Quality Control Strategies,” Monday, April 3, 2:30 p.m., following Hughes’ talk
  • Rapti Madurawe, PhD, Division Director (Acting), Process Assessment I, CDER, FDA, will present “Small Molecule/Continuous Biomanufacturing” in session “C1 — Future Facility Design,” Monday, April 3, 2:30 p.m.

Additionally, breakfast sessions will feature regulatory-focused talks on implementation of new technologies, post-approval changes, knowledge management, quality risk management, data integrity and GMPs for personalized medicines.

For a more personalized view of the importance of parenteral drug manufacturing, in the opening plenary, keynote speaker ,Suleika Jaouad will chronicle her journey as a twentysomething diagnosed with cancer.

More information about these sessions can be found at the 2017 PDA Annual Meeting website: www.pda.org/2017annual.

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