|
Sunday,
October 22, 2006
|
| 5:00
pm - 8:30 pm |
Registration Open - Avoid the lines on Monday! |
|
Monday,
October 23, 2006
|
| 7:30
am - 8:30 am |
Registration
Desk Open / Continental Breakfast |
| 4:30
pm - 5:30 pm |
KEYNOTE
Presentation |
| 5:30
pm - 7:00 pm |
Opening
Reception w/ Exhibitors |
|
Tuesday, October 24, 2006
|
| 7:30
am - 8:30 am |
Registration Desk Open / Continental Breakfast w/ Exhibitors |
|
8:30
am - 9:00 am
|
Regulatory
& Business Context
Why we care
. and how CIP may be of specific
relevance to success or failure in biotech business. |
Ryan
Schroeder
Sr. Associate & Biotech Core Team Leader
CRB Consulting
Engineers
|
| 9:00
am - 10:00 am |
CIP
101
Basic overview of CIP systems, fundamentals, and
terminology. |
Chris
McNulty
Pharmaceutical/Biotech
Product Manager
Sani-Matic Inc.
|
|
10:00
am - 10:30 am
|
Refreshment
Break w/ Exhibitors |
|
10:30
am - 12:00 noon
|
Principles
of CIP-Cleaning Mechanisms
Focus
on variables that lead to effective cleaning, including cleaning
chemicals and mechanical action. |
Chris
McNulty
Pharmaceutical/Biotech
Product Manager
Sani-Matic Inc.
|
|
12:00
noon - 1:00 pm
|
Lunch
w/ Exhibitors |
|
1:00
pm - 2:30 pm
|
CIP
and Regulatory Compliance
Multi
product vs. dedicated product facilities and batch-to-batch vs.
campaign cleaning will be discussed in the light of various applications
and regulatory requirements. |
Rebecca
Brewer
Director, Consultancy Services, Validation and
GMP Compliance
Dober Group
|
|
2:30
pm - 3:00 pm
|
Refreshment
Break w/ Exhibitors |
|
3:00
pm - 4:30 pm
|
CIP
System Design-Skids
CIP skid design considerations including single
vs. mulit-tank configurations, typical CIP cycles and instrumentation
philosophies. |
Chris
McNulty
Pharmaceutical/Biotech
Product Manager
Sani-Matic Inc.
|
|
Wednesday,
October 25, 2006
|
| 7:30
am - 8:30 am |
Registration Desk Open / Continental Breakfast w/ Exhibitors |
| 8:30
am - 10:00 am |
Spray
Devices and Vessel Cleaning
Basic
principles of vessel cleaning, focusing on a review of various
types of static and dynamic spray devices. Equipment applications
and considerations for selection will be analyzed with respect
to process variables and vessel configuration. |
Chris
McNulty
Pharmaceutical/Biotech
Product Manager
Sani-Matic Inc.
|
|
10:00
am - 10:30 am
|
Refreshment
Break w/ Exhibitors |
| 10:30
am - 12:00 noon |
CIP
Fundamentals for Piping Systems
Impacts
of flow, velocity, dead-legs, circuit configuration to piping
system CIP will be reviewed. Criteria for establishing circuit
definition for complex piping systems, including valve and transfer
panel configurations, will be presented. |
Ryan
Schroeder
Sr. Associate & Biotech Core Team Leader
CRB Consulting
Engineers
|
|
12:00
noon - 1:00 pm
|
Lunch
w/ Exhibitors |
|
1:00
pm - 2:30 pm
|
CIP
System Design- Distribution
CIP
supply and return system approaches including transfer panels,
valve matrices, facility and process integration. |
Ryan
Schroeder
Sr. Associate & Biotech Core Team Leader
CRB Consulting
Engineers
|
|
2:30
pm - 3:00 pm
|
Refreshment
Break w/ Exhibitors |
|
3:00
pm - 4:30 pm
|
Qualification
and Cleaning Validation - Part 1 |
Rebecca
Brewer
Director, Consultancy Services, Validation and
GMP Compliance
Dober Group
|
|
Thursday,
October 26, 2006
|
| 7:30
am - 8:30 am |
Registration Desk Open / Continental Breakfast |
|
8:30
am - 10:00 am
|
Qualification
and Cleaning Validation - Part 2 |
Rebecca
Brewer
Director, Consultancy Services, Validation and
GMP Compliance
Dober Group
|
|
10:00
am - 10:30 am
|
Refreshment Break |
|
10:30
am - 12:00 noon
|
In
Process Control and Quality
Approaches to maintaining the validated state
will be discussed relative to such items as routine monitoring,
preventive maintenance, calibration, change control and revalidation. |
Rebecca
Brewer
Director, Consultancy Services, Validation and
GMP Compliance
Dober Group
|
|
12:00
noon - 1:00 pm
|
Lunch
|
|
1:00
pm - 2:30 pm
|
Equipment
Design for CIP-Bioreactors
Detailed
review of a cleaning circuits for a "typical" large
scale cell culture bioreactor. Participants will interactively
discuss and evaluate CIP strategy at the PID level. |
Ryan
Schroeder
Sr. Associate & Biotech Core Team Leader
CRB Consulting
Engineers
|
|
2:30
pm - 3:00 pm
|
Refreshment
Break |
|
3:00
pm - 4:00 pm
|
Integrating
CIP into Complex Manufacturing Sequences
Examples which demonstrate the influence of
cycle duration, circuit complexity and skid utilization on batch
and sequential processing operations are discussed. |
Ryan
Schroeder
Sr. Associate & Biotech Core Team Leader
CRB Consulting
Engineers
|
|
4:00
pm - 5:30 pm
|
PLANT TOUR: BRI Bioprocess
Plant - 50 Maximum |
|
Friday,
October 27, 2006
|
|
9:00
am - 10:30 am
|
PLANT TOUR: BRI Bioprocess
Plant - 50 Maximum |