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ID#
48
: Vendor Night and Presentation: Current FDA Initiatives
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Date: |
9/30/2009
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Location: |
The Desmond at Great Valley
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Cost: |
$65
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Presentation Summary:
Current FDA Initiatives - What are the requirements
and how do we meet them?
This talk will address recent regulatory initiatives at FDA's
Center for Drug Evaluation and Research. FDA has used
risk-based strategies as part of its regulatory process for
over a decade, but has refined its views in guidance and
harmonization processes through its "Pharmaceutical
cGMPs for the 21st Century" (2002) and its "Council for
Pharmaceutical Quality" (2005). As a result of these
efforts, the CMC review program in microbiology is
committed to improving the regulatory process through
Quality by Design (ICH Q8r1) approaches that will
enhance product and process knowledge throughout the
product life-cycle, and also emphasizes these in product
development, e.g., the IND.
Advantages of obtaining product and process knowledge
will be discussed and examples of regulatory initiatives
that work with this knowledge will be presented in the
context of moving toward the desired state in the
pharmaceutical industry.
Intended Audience:
• Production supervisors and management
• Quality Assurance
• Quality Control Engineers
• Critical Systems and Maintenance
• Training Department
• Documentation Department
• Auditing Department
• Legal Departments
Our Speaker:
David Hussong is the Associate Director for New
Drug Microbiology in the Office of
Pharmaceutical Science in FDA's Center for
Drug Evaluation and Research. He directs the
staff that reviews microbiological quality aspects
described in the Chemistry, Manufacturing and
Controls technical section of new drug
applications. He is also a member of USP's
2005 2010 Microbiology and Sterility Assurance
committee.
David earned his M.S. and Ph.D. in microbiology
from the University of Maryland and has served
as a laboratory researcher at the US
Department of Agriculture, and the Office of
Naval Research. He has published several
papers on microbial populations in the natural
environment, and published focused studies of
Salmonella and Legionella that included new
methods for their detection. He also performed
research at FDA's Center for Biologics, studying
antigens of Pertussis and Mycobacteria spp.
He has 25 years of FDA experience and is a
Commissioned Officer in the US Public Health
Service
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Featuring: David Hussong, Associate Director for New Drug Microbiology, CDER, FDA |
| Begin Time |
End Time |
Segment Description |
| 4:00 PM |
7:00 PM |
Cocktails, Networking, Raffle, and Dinner Buffet |
| 7:00 PM |
9:00 PM |
Presentation |
Meeting Flyer (PDF)
Seating at the meeting is limited and menu selections are firm, so it is necessary for you to register to attend by the close of business on the FRIDAY preceding the meeting. Meals are ordered in advance so we can accommodate NO WALK-IN ATTENDEES. Refunds are not available, but substitutions are always welcome, so register early!
Cost for the meeting is $65.00 per person. (We occasionally have seating available after the pre-registration deadline, and last-minute orders may be accepted at $85.00 / person.) All registrations are done via the PDADelVal web site, and we accept credit cards through the site for payment.
If you plan to pay by company or personal check, click the "pay by check" option on the registration page, print two copies of your registration receipt, and either mail us your payment, or bring it to the meeting, including one of your receipt copies. One of our officers will sign the receipt for you.
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