2010 PMF Open Conference on Compendial
Advances - Participating in Change
Open Conference | Register Now | Schedule
| Speakers | Exhibitor/Sponsors
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) |
|