Updated: 2/18/2014
Event:
Track:
Leader:
Dates: Location: Aseptic Conference
Aseptic Processing Technologies and Disposables Jörg Zimmermann and Klaus Ullherr 24 & 25 Feb, 2014
Washington, DC
Monday, 24 February 2014
Start Time End Time Presentation Titles
Speaker Full Name
Speaker's Company
9.00
9.10
9.45
10.20
10.30
11.00
9.10
9.45
10.20
10.30
11.00
11.05
Welcome and Introductions
FDA Perspectives on Aseptic Processing Technologies
Charlotte Enghave Fruergaard
Thomas Arista
Rick Friedman
Thomas Arista, Rick Friedman
NNE Pharmaplan, Denmark
FDA
FDA
FDA
Jörg Zimmermann
11.05
11.45
12.25
12.30
13.30
11.45
12.25
12.30
13.30
14.15
Christine Martin, Ph.D.
Charlie Hitscherich, Ph.D.
Klaus Ullherr
Michael Faia
AstraZeneca, USA
14.15
15.00
Shu‐Chen Chen
Amgen, USA
15.00
15.30
16.15
15.30
16.15
17.00
Applying Lean Principles to Parenteral Clinical Supply Manufacture
Patient Centric Supply Chain
Discussion Group Topics & FDA Questions
Lunch
Challenges in Filling Live Virus Vaccines
Challenges on Physical Container Closure Integrity Testing of Combination Product for Therapeutic Proteins
Networking Break
Isolator concept for the filling of cytotoxic drugs
An introduction to syringe processing: the do's and don'ts
Vetter Pharma Fertigung GmbH Co KG, Germany
Abbvie, Germany
BiogenIdec, USA
Robert Bosch GmbH, Germany
Inga Roswadowski
Jörg Zimmermann
Oncotec, Germany
Vetter Pharma Fertigung GmbH Co KG, Germany
Speaker Full Name
Speaker's Company
Lifecycle Risk Management of Aseptic Processing Operations
Question/Answer Opportunity
Networking Break
Housekeeping and Intros
RECEPTION ‐ 17.00 ‐ 18.30 in Exibit Hall
Tuesday, 25 February 2014
Start Time End Time Presentation Titles
7.30
8.30
8.30
9.15
9.15
10.00
10.00
10.30
10.30
11.15
11.15
11.55
11.55
12.00
13.00
14.30
15.00
15.30
12.00
13.00
14.30
15.00
15.30
17.00
Industry Roundtable: Keys to Addressing Quality System Issues in Aseptic Manufacturing Which May Lead to Shortages
Innovative Use of Disposables
FDA and Industry Leaders
Mayo Pujols
Understanding Isolator Technology: An Engineer’s Guide to Aseptic Processing Sean Goudy
within a Hydrogen Peroxide Decontaminated Environment
Genentech, USA
Networking Break
Upgrading Legacy Systems in Aseptic Area
Latest Recommendations for Control of Particles in the Manufacture and Supply of Single Use Systems
Discussion Group Topics & FDA Questions
Lunch
Discussion groups
Networking Break
Discussion Groups Presentations
FDA Q&A Panel Parag Pande
Merck, USA
Eric Isberg
ATMI, USA
Klaus Ullherr
Robert Bosch GmbH, Germany
Rick Friedman, Associate Director, Office of Manufacturing & Product Quality, FDA/CDER/OMPQ
Bob Sausville, Director, Division of Case Management. FDA/CBER/OMPT/OCBQ
Dave Doleski, Director FDA/CDER/DGMPA
Destry Sillivan, Senior Regulatory Review Officer, FDA/CBER/OMPT Thomas Arista, Investigator/National Expert, Biotech, FDA/ORA/ORO/DDFI
Track Adjourns
Merck Vaccines, USA