2008 PMF Open Conference on Compendial
Harmonization - "New Methods for Old"
February 18-19, 2008
Baltimore, MD
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 in a small, personalized format.
This type of conference
offers a unique small, personalized format for instruction and
discussion.
Register Now
CLICK HERE to register online, or call us at 888-844-8561 (toll-free in US)
Conference Description
The format and purpose of this meeting is somewhat unique. The
compendia play a large role in the activities of the QC
laboratory; our input (into their discussions) is of enormous
benefit to both their deliberations and the quality of the
documents that result. 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.
The conference will start with a Plenary Session consisting
of presentations from regulatory experts providing background
information throughout the first morning . That afternoon
the conference will split into smaller discussion groups
moderated and lead by compendial experts.
The second
morning begin with a keynote address by
Dr. Roger Williams (Exec VP and CEO of USP)
on The Role of USP in the Pharmaceutical Industry.
The second morning will continue with more presentations and small discussion groups
in the afternoon.
Come and pose your questions to those involved in writing the
compendial chapters! This is an unparalleled opportunity to benchmark your
practices not only against current regulatory expectations, but
also against other companies in the industry.
The schedule is available here.
Discussion topics will include:
- Aseptic Processing - USP <1211>, <1116> and the EU Annex
1 changes
- Sterility Tests (USP <71>)
- Bacterial Endotoxin Tests (USP <85>)
- Harmonized Microbial Limits Chapters (<61>, <62>,
<1111>)
- Water Microbiology (USP <1231>)
The full conference brochure is available
here.
Facilitators and Speakers
-
James Agalloco – Agalloco and Associates; USP MSA
(Microbiology and Sterility Assurance Committee of Experts)
-
Ronald N. Berzofsky, Ph.D. - GeneChoice
-
Dennis Guilfoyle, Ph.D. - Lab Chief, FDA/CDER; USP MSA
-
Karen McCullough - MMI Associates
-
Terry Munson – KMI/Parexel, Past USP MSA member, FDA
- retired
-
David Porter, Ph.D. - Vectech Pharmaceutical Consultants,
Past Director, USP
-
Donald Singer -
GlaxoSmithKline; USP MSA
-
TC Soli, Ph.D. - Solipharma Solutions; USP Purified Water
-
Scott Sutton, Ph.D. - Vectech Pharmaceutical Consultants,
USP MSA
-
Radhakrishna Timuralai, Ph.D. - USP Staff Liaison to USP MSA
-
Roger Williams, M.D. - Exec VP and CEO of USP
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.
Venue
This conference will be held at the
Marriott Baltimore Inner Harbor at Camden Yards. Sign up
early to take advantage of the special “Open Conference” room
rate. Reservations at
800-228-9290
Conference Organizers
• The Pharmaceutical Microbiology Forum
•
High Peaks Associates (meeting coordinators)
DOWNLOAD the
Conference Brochure
Open Conference | Register Now | Schedule
| Speakers | Exhibitor/Sponsors
|
