2010 PMF Conference on
Microbial Control - Microbiology in
the Keys
February 22-23, 2010
Key Largo, FL
Open Conference | Register Now | Schedule
| Speakers | Exhibitor/Sponsors
This conference is your opportunity to interact with
international regulators in frank and open discussion on
issues of immediate relevance to the microbiology lab.
This conference will be held in a small, personalized format for instruction and
discussion.
Conference Description
Contaminated finished product is a widespread issue in the
pharmaceutical, medical device and personal products industries,
and the role of microbiology in the prevention of contamination
is far more pervasive than most imagine. All aspects of product
process control (for both sterile and non-sterile products)
contain a microbiological component.
This conference will look at the different aspects of process
and contamination control with an eye to discussing practical measures of
monitoring, control and the setting of appropriate monitoring levels.
It is unique in that the attendees will be presented with the
topics central to contamination control as an integrated topic
and that they will have significant time to spend with the
workshop leaders - all industry experienced and experts.
Major topics will include:
-
Facility monitoring (Environmental and
personnel monitoring, water etc)
-
Process Monitoring (raw material and
in-process checks)
-
Finished product specifications (both
sterile and non-sterile)
-
Cleaning/Sanitization Studies
-
The Contamination Control Plan
The PMF is providing an opportunity
for the membership to meet in small groups with representatives
from regulatory agencies to discuss issues
relating to laboratory operations, GMP and the microbiological
quality of finished products.
Come and pose your questions to industry
thought leaders in a small and personal setting. This is an unparalleled opportunity to benchmark your
practices not only against current regulatory expectations, but
also against other companies in the industry. Facilitators and Speakers
-
Robert Ferer, The Ferer Group
-
David Hussong, Ph.D., FDA/CDER
-
Rick Jakober, Perritt Labs
-
Destin LeBlanc, Cleaning Validation
Technologies
-
John Lindsay, Aseptic Solutions
-
Scott Sutton, Ph.D. - Microbiology Network,
USP MSA
Biographies for the
speakers are available.
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.
CEU & Learning Objectives
The participants in this conference will
be able to receive 1.2 CEU IACET-certified credit (12 contact hours)
upon successful completion of the conference. 
The participants are expected to actively
participate in discussion and questions for the conference - the
unique strength of this conference is the opportunity to discuss
the science behind the regulations.
The learner will:
-
understand the relationships among the different
manufacturing processes that go into the control of
contamination.
-
be able to analyze a
production process for steps likely to affect microbial
bioburden
-
be able to determine
appropriate finished product specifications based on product
type and use, as well as determining affect of test method
capabilities for measuring the product specifications.
-
be able to design and
analyze cleaning and sanitization studies for the
manufacturing facility.
-
understand the regulatory
and scientific requirements for an aseptic facility and how
to qualify and run it with minimal down time.
-
understand the
importance of contamination control in
non-sterile manufacturing facilities,
and how to design a program to monitor
and control this parameter..
Venue
Hilton Key Largo Grande Resort
97000 South Overseas Highway
Key
Largo, Florida 33037
Hotel reservation information will be sent to all registrants
once the minimum enrollment requirements have been achieved to
confirm this conference
Register Now
CLICK HERE to register online, or call us at 888-844-8561 (toll-free in US)
Conference Organizers
• The Pharmaceutical Microbiology Forum
•
High Peaks Associates (meeting coordinators)
Open Conference | Register Now | Schedule
| Speakers | Exhibitor/Sponsors
|
