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Description
The
Biopharmaceutical Industry is focusing more and more on the long-term
life of their equipment and facilities. This focus comes from the challenges
facing the industry, which include
- Increased
Plant Throughput Rates
- Lower
Cost of Goods Manufactured
- Multi-product
Flexibility
This seminar
will focus on those factors which can most influence the successful management
of the BioProcessing Equipment and the Utility Assets within these operating
plants. Operation and Maintenance best practices will be stressed by reviewing
regulatory requirements, actual case studies, and the engineering concepts
to increase long-term asset value.
What
You Will Learn
- Regulatory
requirements for Maintenance programs
- Operational
requirements for long term service of specific types of equipment
- Design
and Material selection considerations for long term service of process
and Utility systems
- How to
establish a Maintenance Program and Procedures for BioProcessing Equipment
- Network
with industry peers, share knowledge and experience
Who
Should Attend
This seminar should be useful for facility engineers, maintenance engineers,
reliability engineers, process engineers, utility engineers, validation
engineers, quality assurance staff, project managers, and maintenance
technicians with 2+ years of experience in manufacturing and operation,
engineering, validation, quality assurance.
Instructor/Speaker
Panel
- Seminar
Director: James Dean Vogel, PE, Principal and Owner, Process Facilities
Services
- John Bennan,
Principal and Owner, ComplianceNet, Incorporated
- John Davis,
Principal Engineer, GE Healthcare UK
- James
Erickson, President and CEO, Blue Mountain Quality Resources
- Paul Kubera,
Vice President, Engineering, ABEC Inc.
- Jan Rau,
PhD, Quality Manager, Dockweiler AG
SCHEDULE
|
MONDAY,
23
JUNE 2008
|
| 7:30
am - 5:00 pm |
Registration
Desk Open |
| 7:30
am - 8:00 am |
Coffee
& Pastries |
| 8:00
am - 8:15 am |
Introduction
and Course Overview |
|
| 8:15
am - 10:00 am |
Operational
and Maintenance Requirements of the BioPharm Industry
A
general review of the business of operations and maintenance of
BioPharmaceutical Equipment and Facilities. It is more than having
an SOP in a book! - Discussion
topics include: Regulatory Requirements (US and EU); Review of how
the practices evolved over time; Compare practices in for both small
and large companies and new and established operations; Define what
it means to stay current.
|
|
| 10:00
am - 10:30 am |
Refreshment
Break |
| 10:30
am - 11:15 am |
DownStream
Equipment Operation and Maintenance
Review
of the specific operation and maintenance practices for downstream
equipment. Focus will be on Chromatography and Filtration Systems.
|
|
| 11:15
am - 12:00 noon |
Bioreactor
Operation and Maintenance
Review
of the specific operation and maintenance practices for upstream equipment.
Focus will be on Bioreactors and Fermentors. |
|
| 12
Noon - 1:00 pm |
Lunch |
| 1:00
pm - 3:00 pm |
Water
and Steam System Operation and Maintenance
Review of the specific operation and maintenance practices
for pure water and steam equipment and systems. Topics include: Pretreatment,
Reverse Osmosis, USP Water Systems, WFI Stills, WFI Water Systems,
Clean Steam Generators, Clean Steam Systems, Support Utilities
|
|
| 3:00
pm - 3:30 pm |
Refreshment
Break |
| 3:30
pm - 4:30 pm |
Reliability
Engineering
An Introduction to the practice of Reliability Engineering.
Focus on predictive maintenance, and integration into the cGMPs.
|
|
| 4:30
pm - 5:30 pm |
Workshop:
Defining your Maintenance Program |
|
|
TUESDAY,
24
JUNE 2008
|
| 7:30
am - 8:00 am |
Coffee
& Pastries |
| 8:00
am - 9:00 am |
Asset
Management Techniques
Review of methods to manage a plant's assets, and how
they all fit together. Electronic Document Management Systems, CADD
drawing files, Equipment Files, Computerized Maintenance Management
Systems, Building Management Systems
|
|
| 9:00
am - 10:00 am |
Computerized
Maintenance Management Systems
Review of CMMS systems and how they function. Operational
principles, and establishment of the systems.
|
|
| 10:00
am - 10:30 am |
Refreshments
Break in Exhibits Hall |
| 10:30
am - 12:00 noon |
Workshop:
Evaluating data, writing procedures, and summarizing system performance |
|
| 12
Noon - 1:00 pm |
Lunch
w/
Exhibitors |
| 1:00
pm - 2:00 pm |
Stainless
Steel Lifecycle and Rouge
A review of stainless steel, its make-up its and
applications in the biopharmaceutical industry. Attention will be
on evaluating length of service. Rouge, evaluation of its formation,
and methods of prevention and remediation will be discussed.
|
|
| 2:00
pm - 3:00 pm |
Plastic
and Elastomer Lifecycle
A review of polymers, their make-up, and their applications
in the biopharmaceutical industry. Attention will be on material selection
and evaluating length of service. |
|
| 3:00
pm - 3:30 pm |
Refreshment
Break in Exhibits Hall |
| 3:30
pm - 4:30 pm |
Workshop:
15-Minute Audit of Team Projects |
|
| 4:30
pm - 5:00 pm |
Case
Studies: Warning Letter and 483 Reviews
Review
of actual Regulatory citations regarding Operations and Maintenance.
|
John
Bennan
Principal
and Owner
ComplianceNet, Inc.
|
| 5:00
pm - 7:00 pm |
Keynote Presentation and Networking Reception in Exhibits Hall |
|
Wednesday,
25 June 2008
|
| 8:00
am - 9:00 am |
Workshop: Learn about the BioProcessing Equipment (BPE) Standard
|
| 9:30
am - |
BPE
Subcommittee Meetings: Open to the Public |
| 3:30
pm - 5:30 pm |
Plant
Tours: GE Healthcare Uppsala / Alfa Laval Tumba
(Seats
are limited. Advance sign-up required.) |
REGISTER NOW!
Visit www.asmeconferences.org/BioprocessEurope08
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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