2008 PMF Environmental Monitoring Workshop
Program
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Exhibitors
Workshop Theme:
A comprehensive
environmental monitoring program is focused on all aspects of
production from the quality of the incoming raw material to the
microbiological profile of the employee.
Companies need to consider all aspects of manufacturing
when defining their environmental monitoring program.
This conference will explore the various aspects
companies should consider when defining a holistic environmental
monitoring program.
Case studies will be used to demonstrate how an effective
environmental monitoring program can help minimize the risk of
adverse regulatory action.
DAY 1:
Monday, March 10, 2008
8:00 – 8:45
am: Registration and
Continental Breakfast
8:45 – 9:00 am:
Welcome and Introduction
Susan Schniepp
9:00 – 10:30 am:
An Overview of a
Comprehensive Environmental Monitoring Program
Valerie
Welter, Plant Quality Manager, Hospira, Inc
Session Description:
This opening session will present a global approach to
environmental monitoring in a manufacturing facility.
All aspects of a comprehensive program will be addressed
and will include advice on how to develop and interpret accurate
and comprehensible data trending metrics regarding environmental
monitoring.
10:30 –
11:00 am – Morning Refreshment Break
11:00 am –
12:30 pm:
Focus on the Standards and Regulations
Susan
Schniepp, Schniepp and Associates, LLC
Session Description:
There are current standards and regulations in place that
establish requirements regarding environmental monitoring.
This session will review the existing information
regarding environmental monitoring and how to interpret them and
their impact on manufacturing.
12:30 – 1:30
pm: LUNCH
1:30 – 3:00
pm:
Focus on Raw Materials
Matthew
Anderson, Director of Supplier Quality, Baxter
Session Description:
A comprehensive environmental monitoring program includes
considering the bio-burden of incoming raw materials.
This session will focus entirely on strategies to
minimize the impact raw materials may have on a company’s
environmental monitoring program as well as discussing key
points to consider when reviewing a supplier’s environmental
monitoring program.
3:00 – 3:30
pm: Afternoon Refreshment Break
3:30 – 5:00
pm:
Focus on People
and Equipment
Tina Sturgill, Director of Microbiological Services,
Celsis Laboratories
Session Description:
This session will discuss the significant role and impact people
and equipment play in establishing a comprehensive environmental
monitoring program.
A discussion of how to interpret and react to data trends from
people and equipment monitoring will be included in this
session.
5:30 – 7:30
pm: Networking
Reception
Day 2:
Tuesday, March 11, 2008
8:30 – 9:00
am: Continental Breakfast
9:00 – 10:30
am:
Focus on Air
Scott Sutton, Senior Director of Microbiologic
Services, Vectech
Proposed
Session Description:
Overall air quality is a paramount concern in environmental
monitoring. This
session will focus on how to establish and maintain the desired
air quality for the various aspects of manufacturing from
incoming material receipt to the actual manufacturing
environment.
Included in this session will be how to establish what the
appropriate monitoring points should be for manufacturing
operations, how frequently areas should be monitored and how to
review and interpret data generated from air monitoring.
10:30 –
11:00 am – Morning Refreshment Break
11:00 am –
12:30 pm:
Focus on Water
Anthony Bevilacqua, Head of Product Development, Mettler/Toledo
Session Description:
Water is a key ingredient for any pharmaceutical manufacturing
operation and maintaining its quality is a major consideration
in establishing a comprehensive environmental monitoring
program. This
session will discuss the various types of water that can be used
in manufacturing and identify the critical parameters to be
continuously monitored and trended to ensure the high water
quality needed for manufacturing is maintained.
12:30 – 1:30
pm: LUNCH
1:30 – 3:00
pm:
How to Handle Deviations and Excursions
Brenda
Sullivan, Microbiology Plant Quality Manager, Hospira, Inc
Session Description:
Consideration of incoming raw materials, supplier quality,
people, equipment, air, and water quality to establish a
comprehensive environmental monitoring program that assures the
appropriate conditions are maintained for pharmaceutical
manufacturing. Interpreting and reacting to deviations and
excursions generated through data trending is critical in
determining the overall suitability of an environmental
monitoring program.
This session will discuss a practical approach to handling and
reacting to deviations and excursions obtained during the
monitoring of the various aspects on a comprehensive
environmental monitoring program.
3:00 – 3:30
pm: Afternoon Refreshment Break
3:30 – 5:00
pm:
How to Handle Regulatory Inspections:
Panel Discussion
Brenda
Sullivan (30 minute presentation)
Panelists:
Scott Sutton, Valerie Welter, Brenda Sullivan, Matthew
Anderson, Anthony Bevilaqua, Tina Sturgill, Susan Schniepp
This panel
discussion will begin with a 30 minute presentation about how to
present and explain the environmental monitoring program to
regulatory inspectors with specific emphasis on addressing
deviations and excursions.
After the presentation the expert panel will address
questions from the participants in an open forum.
End
of Workshop
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