Event:
Session:
TAMPA 2011 CONFERENCE
Dates:
Location:
Web Link:
Monday and Tuesday 21-22 February 2011
Tampa, FL
http://www.ispe.org/2011tampaconference/asepticprocessing
Aseptic Processing of Sterile Products:
Innovations, Regulatory Guidance and
Compliance in a Practical World
Session LeadManmohan Sihra, Ryan Hawkins
Monday, 21 February
Start
Time
7:00
7 30
7:30
9:00
End
Time
8:00
9:00
9 00
9:15
Presentation Title
Speaker / Leader Breakfast (invitational)
Breakfast
B kf
Welcome and Introductions
Speaker Full Name Company
Total
min.
Manmohan Sihra
Ryan Hawkins
Sihra Consulting 15
Cook Pharmica
10:00 12 Things You Can Do to Reduce
Contamination Risk
10:00 10:30 Networking Break
10:30 11:15 Challenges of Sterile Filtration
Jack Lysfjord
Lysfjord
Consulting
45
Jerold Martin
45
11:15 12:00 Best Practices for Product Inspection
Michael de la
Montaigne
Pall Life
Sciences
Eisai
Merritt Postma
IMA Edwards
45
Benoit Verjans
Aseptic
Technologies
45
9:15
12:00 13:00 Lunch
13:00 13:45 New Filling Technology - Modulator Aseptic
Concept of Filling
13:45 14:30 Closed Vial Technology
14:30 15:00 Networking Break
15:00 15:45 Controlled Product Nucleation through the
Introduction of Sterile Nitrogen Ice Fog
15:45 16:30 Effect of Residual Vaporized Hydrogen
Peroxide on Protein Products
16:30 17:00 Q&A for Today
Prerona Chakravarty IMA Life North
America
Frank DeMarco
Edwards
Pharmaceutical
S
Systems
Mike Walsh
Lilly
Manmohan Sihra
Ryan Hawkins
45
45
45
Sihra Consulting 30
Cook Pharmica
16:30 17:00 Seminar Adjourns, Reception in Exhibit Hall
Tuesday, 22 February
Start
Time
7:30
9:00
End
Time
9:00
9:15
Presentation Title
Breakfast
W
l
t D
T
Welcome
to
Day Two
Speaker
Manmohan Sihra
Ryan Hawkins
Total
min.
Sihra Consulting 15
Cook Pharmica
9:15 10:00 Isolator Filling Line Case Study
10:00 10:30 Networking Break
10:30 11:15 Gowning Challenges for Aseptic Operations
Ryan Hawkins
Cook Pharmica
45
Joerg Zimmerman
Vetter
45
11:15 12:00 Single-use Disposable Systems (SUDs) for
Aseptic Fill/Finish: Concepts and Application
Rob Roy
Jason Collins
IPS
IPS
45
12:00
12
00 13:00
13 00 Lunch
L
h
13:00 13:45 An Overview of the updated ISPE Sterile Guide Mark von Stwolinski CRB Consulting
This is an overview of the second edition of ISPE’s
Engineers
Baseline Pharmaceutical Engineering Guide for New
and Renovated Facilities Volume 3 ‘Sterile
Manufacturing Facilities’ which was originally published
in 1999. ISPE Guides aim to describe current good
practices that can help
p
p a company
p y develop
p an approach
pp
that is effective, cost-efficient and in compliance with
existing regulations and related guidance, while allowing
a flexible and innovative approach to facility design,
construction, commissioning, and qualification.
The key items presented will be:
• Identifying the individuals involved with these updates
• The process for getting to this second edition
• What has change in the Guide and why
•H
How this
thi updated
d t d Guide
G id can help
h l better
b tt assist
i t the
th
industry
13:45 14:30 Update on PDA Aseptic Process Simulations
Technical Report (TR22) Revisions
14:30 15:00 Networking Break
15:00 15:45 Environmental Monitoring in Aseptic
Operation
15:45 16:30 Effect of Advances in Aseptic on Regulation
16 30 17:00
16:30
17 00 Q&A ffor T
d
Today
17:00
Seminar Adjourns
Tony Pavell
APP Pharma
45
Michael Miller
45
Jim Akers
Microbiology
Consultants
Akers Kennedy
M
Manmohan
h Sihra
Sih
Ryan Hawkins
Sih
Sihra C
Consulting
lti
30
Cook Pharmica
45
0