Event:
Session:
TAMPA 2010 CONFERENCE
Session Leader:
Dates:
Location:
E07- Technology Transfer: Focus on the Business Process and
Practical Execution
Mike Denault, Jeff Odum
Wednesday-Thursday 24-25 February 2010
Tampa, FL
*Accurate as of 01/26/10*
Wednesday, 24 February
Start
Time
End
Time
Presentation Title
7:30
9:00
9:00
9:15
Breakfast
Technology Transfer: Solving the Mystery of Execution
This presentation will outline the key focus areas of Technology Transfer
today and introduce many of the session topics for the audience.
9:15
10:30
Business and Execution of Tech Transfer
Speaker
Phillips
Dinan
Kranking, Moderator
API Technology Transfer; Development to Commercial:
This session segment will describe an approach to Technology Transfer
for API processes transitioning from development to manufacturing with
emphasis on the management of the TT process. Project initiation,
document and management structures as well as project governance will
be discussed
Business and Cultural Issues for Technology Transfer:
This session segment will discuss some of the issues faced as companies
take tech transfer activities out-of-country. The primary discussion will
focus on Asia-US challenges related to communication, documentation,
regulatory interpretation, and customs.
10:30
11:00
11:00
12:00
Break
The FDA Perspective on Technology Transfer Implementing ICH Q8, Morefield, FDA
Q9, and Q10 Guidance
The focus of this presentation will be on:
● Scaling up a design space
● Using Risk Management in scale-up
● The role of Quality Systems in Tech Transfer activities
12:00
13:00
13:00
13:45
Lunch
Panel w/FDA
Forum: Discussing the issues and challenges of Tech Transfer
This forum will follow the "town hall meeting" format and allow the
attendees to ask questions of all the session panelists. Questions can be
submitted in advance to ISPE for discussion in this interactive session.
13:45
14:00
Workshop: In this interactive session, attendees will have the opportunity Kranking
to work in teams on problems taken from "real life" technology transfer
projects. Teams will be given project information and scenarios and be
asked to respond to questions and develop deliverables for discussion
with their peers and the session panelists.
14:00
15:00
Workshop: Teams continue their interactive session, with facilitation from Groups Work
the panelists.
15:00
15:30
16:30
17:00
15:30
16:30
17:00
Break
Workshop Activity continued
Sharing, Wrap Up
Seminar Adjourns, Reception
Kranking
Groups Present
Thursday, 25 February
Start
Time
End
Time
Presentation Title
Speaker
7:00
8:00
8:15
8:00
8:15
9:15
Breakfast
Welcome to Day Two
Denault
Writing The Owner’s Manual, Dealing With the Spaghetti: Key Issues Linden
in Manufacturing Contracts
This session segment will focus on the often overlooked business issues
of Tech transfer efforts, especially the contractual items that can lead to
failure of the Tech Transfer effort. At the conclusion of this session,
participants will have a better understanding of:
● Some key issues in manufacturing contracts
● What is important to think about when negotiating a manufacturing
contract
9:15
10:30
Risk Assessment Applications for Tech Transfer: Understanding the
Risky Business Behind Tech Transfer
This session segment will look at how risk assessment should be
implemented during Tech Transfer activities and how some companies
have been successful (or not) in understanding the ramifications of risk.
Included in this session will be open discussions from FDA on Q9
applications in Tech Transfer efforts.
10:30
11:00
11:00
12:00
Break
Breakout Sessions: These sessions will provide attendees the
opportunity to work on problems in the areas of:
● Risk Assessment and Implementation of Q9
● Business and contract implementation
12:00
13:00
13:00
14:30
Lunch
Workshop: In this activity, attendees will be given different "project"
scenarios involving tech transfer activities. The goal of this workshop is to
present opportunities for the teams to develop responses to issues that
are commonly found in tech transfer activities that can lead to delays and
even failure.
Odum
Phillips
Morefield, FDA
Denault
14:30
15:00
16:00
15:00
16:00
Break
Sharing, Wrap Up
Seminar Adjourns
Groups Present
**Please note that Agendas are subject to change**
Denault
Phillips
Morefield, FDA
Odum, Moderator
Denault
Morefield, FDA
Phillips
Kranking
Odum
Linden