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THIS
SEMINAR HAS BEEN CANCELED
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; and Multiproduct Flexibility.
This seminar
will focus on those factors which can most influence the successful management
of the BioProcess 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 2-8 yrs of experience in manufacturing and operation,
engineering, validation, quality assurance.
EXPERT
PANEL:
- DIRECTOR:
James Dean Vogel, P.E.,
Principal, Process Facilities Services
- John Bennan,
Principal and Owner, ComplianceNet, Incorporated
- Paul
Kubera, Vice President, Technology, ABEC
- Peter
Petrillo, Principal, Millenium Facilities Resources, Inc.
- Marc
Pelletier, Director, Strategic BioPharm Solutions Group, CRB Consulting
Engineers
- Jeff
Pouliot, Process Engineer, Amgen
AGENDA
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Monday,
10 November |
| 8:00-8:30
am |
Opening
Remarks
- James Dean Vogel, P.E., Principal,
Process Facilities Services |
| 8:30-10:00
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
-
James Dean Vogel, P.E., Principal, Process Facilities Services
- John Bennan, Principal and Owner, ComplianceNet, Incorporated |
| 10:00-10:30
am |
Coffee
Break |
| 10:30-11:15
am |
BioReactor
Operation and Maintenance
Review of the specific operation and maintenance practices
for upstream equipment. Focus will be on Bioreactors and Fermenters.
- Paul Kubera, Vice President,
Technology, ABEC |
| 11:15-Noon |
DownStream
Equipment Operation and Maintenance
Review of the specific operation and maintenance practices for downstream
equipment. Focus will be on Chromatography and Filtration Systems.
|
|
Noon-1:00 pm |
Lunch |
| 1:00-2:30
pm |
Water
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.
-
Peter Petrillo, Principal, Millenium Facilities Resources |
| 2:30-3:00
pm |
Asset
Management Techniques
Review of methods to manage a plant's assets and how they all fit
together. Electronic Management Document Systems, CADD drawing files,
Equipment files, Computerized Maintenance Management Systems, Building
Management Systems
-
James Dean Vogel, P.E., Principal, Process Facilities Services |
| 3:00-3:30
pm |
BREAK;
coffee/refreshments |
| 3:30-4:30
pm |
Computerized
Maintenance Management Systems
Review of CMMS systems and how they function. Operational principles,
and establishment of the systems.
-
James Dean
Vogel, P.E., Principal, Process Facilities Services |
|
4:30-5:30
pm |
Work
Shop-Define your Maintenance Program
An interactive workshop where the class will break into groups and
generate operational and Maintenance programs and procedures. They
will function under a simulated project and facility operation scenario.
Session I: Establish the Program.
-
James Dean Vogel, P.E., Principal, Process Facilities Services
- John Bennan, Principal and Owner, ComplianceNet, Incorporated
- Peter Petrillo, Principal, Millenium Facilities Resources
|
|
Tuesday,
11 November |
| 8:00-9:00
am |
Reliability
Engineering
An Introduction to the practice of Reliability Engineering.
Focus on predictive maintenance, and integration into the cGMPs.
-
James R. Erickson, President and CEO, Blue Mountain Quality Resources,
Inc. |
| 9:00-10:00
am |
Stainless
Steel Lifecycle and Rouge
A review of Stainless Steel, its make-up and its 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.
-
Jeff Pouliot, Process Engineer, Amgen |
| 10:00-10:30
am |
Coffee
Break |
| 10:30-11:30 |
Work
Shop-Evaluate your data, Write you procedures, and Summarize your
system performance
An interactive workshop where the class will break into groups and
generate operational and Maintenance programs and procedures. They
will function under a simulated project and facility operation scenario.
Session II: Write your procedures and evaluate the data.
-
James Dean Vogel, P.E., Principal, Process Facilities Services
- John Bennan, Principal and Owner, ComplianceNet, Incorporated
- Peter Petrillo, Principal, Millenium Facilities Resources |
11:30-12:00 |
Steam
System Operation and Maintenance
Review of the specific operation and maintenance practices for pure
steam equipment and systems.
-
Peter Petrillo, Principal, Millenium Facilities Resources |
| Noon-1:00
pm |
Lunch |
| 1:00-2:00
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.
-
Jeff Pouliot, Process Engineer, Amgen |
|
2:00-3:00 pm |
Water
and Steam System Predictive Maintenance
A review of a novel method to track rouge formation in a system and
assess the effectiveness of the derouging event. Attention will be
on evaluating length of service.
-
Peter Petrillo, Principal, Millenium Facilities Resources
|
| 3:00-3:30
pm |
Coffee
BREAK |
|
3:30-4:30
pm |
Work
Shop-15 Minute Audit of Team Projects
An interactive workshop where the class will break into groups and
generate operational and Maintenance programs and procedures. They
will function under a simulated project and facility operation scenario.
Session III: Defend your program and procedures to an auditor.
- James Dean Vogel, P.E., Principal,
Process Facilities Services
- John Bennan, Principal and Owner, ComplianceNet, Incorporated
-
Marc Pelletier, Director, Strategic BioPharm Solutions Group, CRB
Consulting Engineers
-
Peter Petrillo, Principal, Millenium Facilities Resources
|
| 4:30-5:00
pm |
Case
Studies: Warning Letter and 483 Reviews
Review of actual Regulatory citations regarding Operations and Maintenance
-
John Bennan, Principal and Owner, ComplianceNet, Incorporated |
| 5:00-7:00
pm |
Keynote
and Cocktail Reception (with Exhibitors) |
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Friday,
14 November
|
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9:00 am
- 11:00 am: Plant Tour of Amgen-Juncos (Seats are limited. Advance
sign-up required.) |
REGISTER
NOW! Visit www.asmeconferences.org/Bioprocess08
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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