2008 PMF Workshop on
Environmental Monitoring
The ABCs of Environmental Monitoring: Its Not Just in the
Air
March 10-11, 2008
Presented by the Pharmaceutical Microbiology Forum
This workshop is your opportunity to interact with
regulators and thought leaders in frank and open discussion on
issues of immediate relevance to the manufacturing environment.
Workshop Home Page | Register | Schedule
| Speakers | Exhibitors
CLICK HERE to register online, or call us at 888-844-8561 (toll-free in US)
Workshop Description
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
workshop 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.
The workshop will be focused on critical aspects of the
environmental monitoring program:
- Components of a Comprehensive Environmental Monitoring
Program
- Standards and Regulations
- Raw Materials
- People and Surfaces
- Air
- Water
- Trending, Databases, Deviations and Excursions
- Regulatory Inspections
Learning Objectives
Workshop attendees will be able to:
- Understand and be able to implement a holistic
environmental monitoring program
- Appreciate and discuss the role of the
Environmental Monitoring program in demonstrating a state of
control of the facility through trending and analysis of the
data and the importance of databases in this effort
- Understand the regulations and standards that
govern environmental monitoring
- Understand the importance of complete and thorough
microbial deviation reports for regulatory inspections
purposes
- Understand how to minimize the impact incoming
materials may potentially have on the manufacturing
environment
- Understand the impact air quality, water quality,
people and equipment have on the manufacturing environment.
- Understand the various types of compendial waters
used in manufacturing and how to maintain their "suitability
for use"
- Learn how to present complicated environmental data to
regulatory inspectors
Who Should Attend
The meeting will be of particular interest to pharmaceutical
microbiologists and microbiology laboratory managers, contract
laboratory microbiologists and managers, pharmaceutical
manufacturers, and individuals concerned with the regulatory
aspects of microbial control.
Program
A program for the workshop is available
here.
Venue
Doubletree Hotel Philadelphia
237 South Broad Street
Philadelphia, PA USA
Reservations may be made by calling 800-222-8733. Please
mention “Environmental Monitoring” to receive the reduced room
rate of $195/night. This rate is effective until February 21,
2008.
Workshop Facilitator:
Susan
Schniepp, Schniepp and Associates, LLC
Workshop Organizers
• The Pharmaceutical Microbiology Forum
•
High Peaks Associates (meeting coordinators)
Workshop Home Page | Register | Schedule
| Speakers | Exhibitors |
