2014 ISPE Aseptic Conference

Regulatory Panel

Regulators to provide current perspectives on Aseptic challenges and answer your questions during interactive panel discussion.

Questions and issues emerging from conference presentations and discussions will be presented for the regulatory panel to address during the concluding session.  You won’t want to leave early from this conference!

Participating Regulators:

 PhotoRick Friedman
Associate Director, Office of Manufacturing and Product Quality, FDA/CDER, USA

 PhotoDave Doleski
Director, Division of DGMPA, FDA/CDER, USA

 PhotoDestry Sillivan
Senior Regulatory Review Officer, FDA/CBER/OMPT, USA

 PhotoThomas Arista
Investigator/National Expert-Biotech, FDA/ORA/ORO/DDFI, USA

Bob Sausville
Director, Division of Case Management,FDA/CBER/OMPT/OCBQ, USA

View Other Tracks:

Aseptic Processing Technologies and Disposables

Barrier Isolation – RABS Track

 

 

Announcements:

Handouts are now available!