2008 PMF Conference on Microbial Data
Deviations and Investigations
May 19-20, 2008
Presented by the
Pharmaceutical Microbiology Forum
This conference is your opportunity to interact with regulators
and thought leaders in frank and open discussion on issues of
immediate relevance to the manufacturing environment.
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Conference
Description
Microbiologists play a prominent role in sampling, testing,
analyzing and interpreting results for products that are used by
millions of individuals around the world. For products
manufactured under cGMP guidelines, the microbial criteria used
to release them into the market are usually quite clear – the
product either meets the specifications and is released, or does
not meet them and is rejected. However when the results are
equivocal, products are frequently rejected because there are
few precedents to help microbiologists interpret these data.
This seminar will help microbiologists, and their management
teams, interpret Out-Of-Specification results and will provide
pragmatic alternatives to automatic product rejection as seen
from the perspective of industry veterans who have been there,
done that. The seminar will provide practical approaches to
interpreting microbiological Out-Of-Specifications (Microbial
Data Deviations - MDD) and will examine their implications on
the decision making process.
Topic List
This conference will focus on the particular needs of
investigations for microbiology related issues in the QC lab, in
environmental monitoring, and in support of manufacturing.
Specific topics will include:
- Product Recalls
- Raw materials
- Clean rooms
- Water systems
- Preservatives
- Endotoxins
- Environmental monitoring
- Finished products
- Molds and Yeasts
Speakers
- Dilip Ashtekar, Amgen
- Anita Bawa, Genentech
- Anne Marie Dixon, Cleanroom Management Associates,
Inc.
- Phil Geis, Procter & Gamble
- Victor Ma, Novartis
- Karen McCullough, MMI Associates
- Frank Settineri, Veracorp, Inc.
- Scott Sutton, Ph.D., Vectech
- Anethra Wilson, Imclone
- Karen Zimm, Johnson & Johnson
Learning Objectives
Workshop attendees will be able to:
- Objectively analyze microbial excursions for root cause
and for significance.
- Ask appropriate questions to uncover unapparent reasons
for a microbial excursion.
- Help management understand that a microbial excursion
does not automatically indicate product rejection.
- Learn to distinguish between an excursion based the
product's failure of a critical quality attribute and
invalid test results.
- Become familiar with precedents set by others to avoid
unnecessary product rejection.
- Understand the implications of a product recall.
- Defend their position with confidence based upon a
scientific foundation.
Who Should Attend
The meeting will be of particular interest to:
- Microbiology Laboratory supervisors and Microbiologists
responsible for testing and release of Pharmaceutical,
Parenteral and Medical Device products.
- Regulatory and Compliance Personnel responsible for
auditing of manufacturing facilities and QA and Contract
Microbiology Laboratories.
- Contract laboratory microbiologists and managers Quality
Assurance Professionals
- Individuals responsible for disposition of products that
are associated with microbiological OOS results.
Book
Pharmaceutical Quality Control
Microbiology: A Guidebook to the Basics
by Scott Sutton will be provided to each participant - a $200
value! Meet the author at this conference!
Venue:
Sheraton Gateway Hotel - SFO Airport, 600 Airport Blvd.
Burlingame, CA
Reservations: 800 325-3535 - Mention "MDD" to receive group rate
of $139/night. This rate expires May 5.
Conference
Facilitator
Frank
Settineri, Veracorp
Workshop
Organizers
• The Pharmaceutical Microbiology Forum
• High Peaks Associates (meeting coordinators)
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