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This
course is now available on CD-ROM. To purchase, please call 800-843-2763.
Description
This
course will provide a comprehensive study of bioprocess technology
implementation in GMP manufacturing facilities, as well as instruction
on the latest trends, strategies and techniques that are employed
by industry leaders to successfully execute time & resource limited
projects in a regulated environment. Class discussion, workshop exercises
and case studies will be employed to explore all aspects of equipment
and facility delivery, including strategic planning, technology transfer,
programming, bioprocess design, equipment sourcing, automation, construction,
commissioning and validation.
What You Will Learn
- Understand
and apply key techniques used by leading biologics manufacturers
for process technology transfer and implementation.
- Learn industry
best practices for the design and delivery of biopharmaceutical
facilities & equipment.
- Evaluate the
feasibility of new and renovated bioprocess manufacturing systems,
and generate a realistic execution plan, cost & schedule to
submit for capital approval.
- Apply proven
techniques to successfully deliver bioprocess equipment while meeting
production, compliance, budget and schedule constraints.
- Participate
in multiple discussions, case studies and workshops while networking
with industry peers, sharing knowledge and experience.
Who Should Attend
This course is an essential resource for engineers, scientists and
managers who are involved in bioprocess technology development, transfer
and implementation via the design and delivery of biologics manufacturing
facilities. Our informative and practical approach to bioprocess systems
implementation will be especially useful to engineers, consultants,
project suppliers and end users that are involved in the creation
of new, expanded or renovated GMP facilities. Attendees should have
a basic understanding of project management principles and bioprocess
unit operations.
Schedule
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Sunday,
October 22, 2006
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| 5:00
PM - 8:30 PM |
Registration Open - Avoid the lines on Monday! |
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Monday, October 23, 2006
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| 7:30
am - 8:30 am |
Registration Desk Open / Continental Breakfast |
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8:30
am - 9:00 am
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Introduction
& Class Orientation
Solicit questions for panel discussion |
David
Marks
President & Senior Consultant
DME Alliance Inc.
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|
9:00
am - 10:00 am
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Implementing
New Technologies for Bioprocess Manufacturing
How to develop, characterize, confirm and
roll-out new technology for GMP manufacturing within on organization. |
|
|
10:00
am - 10:30 am
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Refreshment
Break |
|
10:30
am - 12:00 noon
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Bioprocessing Equipment Technology
This session will be a survey of best practice
for the design of bioprocess systems. Industry standards, including
the ASME BPE, GAMP and ISPE baseline guides, will be introduced
as key tools that can be leveraged to control quality and contain
costs. Trends in regulatory compliance and global standardization
will be examined. |
David Marks
President & Senior Consultant
DME Alliance Inc.
|
|
12:00
noon - 1:00 PM
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Lunch |
|
1:00
PM - 2:30 PM
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Bioprocess
Automation Technology
This session will discuss the issues associated
with introducing process automation technology to GMP bioprocess
manufacturing including automation design and development. |
|
|
2:30
PM - 3:00 PM
|
Refreshment
Break |
|
3:00
PM - 4:30 PM
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Bioprocess Technology & GMP Facility Delivery - Lessons
Learned
A practical review of biopharmaceutical facility
design and construction with case studies and instructional emphasis
on common mistakes and technology implementation problems encountered
during execution. |
|
| 4:30
PM - 5:30 PM |
KEYNOTE
Presentation |
| 5:30
PM - 7:00 PM |
Opening
Reception w/ Exhibitors |
|
Tuesday,
October 24, 2006
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| 7:30
am - 8:30 am |
Registration Desk Open / Continental Breakfast w/ Exhibitors |
| 8:30
am - 10:00 am |
Bioprocess
Technology Transfer
An in-depth analysis of issues associated with
bioprocess technology transfer for the design and delivery of
biologic manufacturing facilities to remote sites in North America,
and Europe. |
|
|
10:00
am - 10:30 am
|
Refreshment
Break w/ Exhibitors |
| 10:30
am - 12:00 noon |
The
Future of Bioprocess Design - Technologies & Trends
Panel discussion on key technology issues facing
our industry, including modularization, the use of disposables,
contamination control, process analytical technology and regulatory
initiatives. |
Panel
Discussion
(all instructors)
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12:00
noon - 1:00 PM
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Lunch
w/ Exhibitors |
|
|
Pilot
Plant Delivery - Technology Implementation to Accommodate the
Uncertain Process
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|
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2:30
PM - 3:00 PM
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Refreshment
Break w/ Exhibitors |
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3:00
PM - 4:30 PM
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Startup,
Commissioning & Qualification of Bioprocess Facilities
This presentation will focus on the challenges
associated with the commissioning and qualification of biologics
manufacturing facilities. |
|
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Wednesday,
October, 25, 2006
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| 7:30
am - 8:30 am |
Registration Desk Open / Continental Breakfast w/ Exhibitors |
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8:30
am -10:00 am
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Bioprocess
Equipment Sourcing Strategies
This session will examine sourcing issues associated
with bioprocess systems, including supplier qualification, procurement
strategies and vendor selection. The leading causes of poor supplier
performance and how to prevent them will be examined. |
David
Marks
President & Senior Consultant
DME Alliance Inc.
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|
10:00
am - 10:30 am
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Refreshment Break w/ Exhibitors |
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10:30
am - 12:00 noon
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Strategic
Planning and Conceptual Design for Biopharmaceutical Facilities
Instruction will focus on the methodology required
to evaluate the feasibility of projects involving new or renovated
bioprocess systems, and create a conceptual design that addresses
user requirements. |
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12:00
noon - 1:00 PM
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Lunch
w/ Exhibitors |
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1:00
PM - 2:30 PM
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Workshop
- Strategic Planning and Conceptual Design for Biopharmaceutical
Facilities
Workshop exercises will apply the methods and techniques
associated with the conceptual design of a typical biologics process. |
|
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2:30
PM - 3:00 PM
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Refreshment
Break w/ Exhibitors |
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3:00
PM - 4:30 PM
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Workshop - Strategic Planning and Conceptual Design for Biopharmaceutical
Facilities
Workshop exercises will apply the methods and
techniques associated with the conceptual design of a typical
biologics process. |
|
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Thursday,
October 26, 2006
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| 7:30
am - 8:30 am |
Registration Desk Open / Continental Breakfast |
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8:30
am - 10:00 am
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Capital
Project Execution - Implementing Progress & Performance Measurement
Systems
Describing the use and importance of implementing
progress and performance measurement systems for engineering,
construction, validation and other professional services employed
during the execution of a capital project. This session will describe
why such processes are needed and how to implement, analyze, and
follow-up with these "systems" once developed. |
James L. Whitman
Director - Project Controls Group, Global Engineering
Services,
Wyeth
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10:00
am - 10:30 am
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Refreshment
Break |
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10:30
am - 12:00 noon
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Project
Delivery Systems for Bioprocess Manufacturing Facilities
This presentation will address the project delivery
systems that are required to ensure the successful delivery of
bioprocess systems that are in compliance, in budget, within schedule
and achieve user requirements. |
James
L. Whitman
Director - Project Controls Group, Global Engineering
Services,
Wyeth
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12:00
noon - 1:00 pm
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Lunch
/ Course Concludes |
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4:00
PM - 5:30 PM
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PLANT TOUR: BRI Bioprocess
Plant - 50 Maximum |
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Friday,
October 27, 2006
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9:00
am - 10:30 am
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PLANT TOUR: BRI Bioprocess
Plant - 50 Maximum |
ASME
Travel Policy : ASME
is not responsible for the purchase of non-refundable airline tickets
or the cancellation/change fees associated with canceling a flight.
Please call to confirm that the course is running before purchasing
airline tickets. ASME retains the right to cancel a course up until
3 weeks of the scheduled presentation date.
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