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2010 PMF Open Conference on Compendial Advances - Participating in Change

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SCHEDULE

The conference will be devoted to a discussion of the international regulatory climate with special emphasis on harmonized compendial chapters, and recently implemented chapters of the USP.  The conference will provide instruction and an opportunity for discussion of:

  • The exploration of the continuum of the microbial control and test in the manufacture of sterile pharmaceutical products
  • The determination of the inconsistencies in compendial, regulatory and industrial practices in microbial control (and the identification of how they could be made more consistent)
  • The establishment of consensus positions whenever possible.

The afternoons of the conference will be devoted to discussion with compendial and regulatory experts on the following general topics:

  • Clean Rooms and Process control
  • Microbial Identification (<1113>)
  • Best Lab Practices (<1117>)
  • Non-sterile production
  • Water Microbiology (USP <1231>)

Biographies for the speakers and discussion facilitators are available here.


Schedule

January 25th 
8:00 - 8:30 Registration and Continental Breakfast
8:30 am - 8:45 am Welcome
Scott Sutton
8:45 am - 9:30 am Keynote Address
On The Importance of Participation
Susan De Mars, J.D. 
9:30 am - 10:15 am

Microbiology Best Lab Practices - New Draft
Don Singer

10:15 am - 10:45 am  Break
10:45 am - 11:30 am Non-sterile Manufacturing - New Chapter
Len Mestrandrea, Ph.D.
11:30 am - 12:30 pm Water Testing - New Draft
T.C. Soli, Ph.D.
12:30 pm - 1:30 pm Lunch
1:30 pm - 3:00 pm Discussion Session #1
3:00 pm - 3:30 pm Break
3:30 pm - 5:00 pm Discussion Session #2
5:00 pm - 7:00 pm Reception (Casual Dress)

January 26th 
7:30 - 8:00 Continental Breakfast
8:00 - 9:00 am Microbial Identification - New Draft
Scott Sutton, Ph.D.
9:00 am - 10:00 am Clean rooms and process control - New Draft
David Hussong, Ph.D.
10:00 am - 10:30 am  Break
10:30 am - 11:15 am Harmonized Referee Tests:
   - Microbial Limits Tests
   - Sterility Tests
   - Bacterial Endotoxin Tests
Radha Timuralai, Ph.D.
11:15 am - 12:00 pm  Reference Chapters
David Porter, Ph.D.
12:00 pm - 1:00 pm Lunch
1:00 pm - 2:30 pm Discussion Session #3
2:30 pm - 3:00 pm Break
3:00 pm - 4:30 pm Discussion Session #4
4:30 pm Conference ends

 


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