Get Your Burning Aseptic Questions Answered by Regulators
Marking its 27th year, the annual ISPE Aseptic Conference continues to be the place to go to for the latest and greatest in barrier/isolation technology, small and large scale aseptic manufacturing, robotics, and disposables. The conference presents fantastic opportunities to interact with pharmaceutical industry leaders, experts, and regulatory agencies. The pinnacle of the conference remains the regulatory discussion panel, where attendees and colleagues with interest can submit questions for the regulators in attendance to answer. The 2018 ISPE Aseptic Conference will be held in Reston, Virginia March 6-7, with the following regulatory representative taking part in the annual tradition:
- Robert Sausville, Director, FDA/CBER/OCBR/DCM
- Rebecca Dombrowski, USFDA/CDER/OPQ/OPF/DIA/IABI
- Lynne Ensor, PhD, CDER/OPQ/OPF/DMA
- Rick Friedman, USFDA/ CDER/OC/OMQ
- CDR Jeremy Wally, PhD, USFDA/CBER/OCBQ/DIS
- Thomas Arista, FDA/ORA/ORO/DMPTO
The 2018 ISPE Aseptic Conference presents a fantastic opportunity to interact with pharmaceutical industry leaders, experts, and regulatory agencies. Information shared during the regulatory Q&A session will be available for attendees after the conference. Although we must all be reminded that as attendees, the participants comments are considered opinions only, and cannot be viewed as statements by the FDA; however they do provide insight into current directions and risk points to be considered when operating aseptic facilities. The Q&A session is open to all conference attendees, with the question pool being generated from conference attendees via the ISPE website, additionally during the Q&A session there is an open microphone option for brave attendees to ask their questions directly.
With the conference quickly approaching, we look forward to hosting and seeing you there.