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
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.