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.

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:

1. Understand and be able to implement a holistic
environmental monitoring program
2. 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
3. Understand the regulations and standards that govern
environmental monitoring
4. Understand the importance of complete and thorough
microbial deviation reports for regulatory inspections
purposes
5. Understand how to minimize the impact incoming materials
may potentially have on the manufacturing environment
6. Understand the impact air quality, water quality, people
and equipment have on the manufacturing environment.
7. Understand the various types of compendial waters used in
manufacturing and how to maintain their "suitability for use"
8. 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)