[Federal Register Volume 76, Number 86 (Wednesday, May 4, 2011)]
[Notices]
[Page 25358]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-10764]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
2011 Parenteral Drug Association/Food and Drug Administration
Glass Quality Conference; Public Conference
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public conference.
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SUMMARY: The Food and Drug Administration (FDA), in cosponsorship with
the Parenteral Drug Association (PDA), is announcing a public
conference entitled ``PDA/FDA Glass Quality Conference--Best Practices
to Prevent and/or Detect At-Risk Glass Packaging.''
Date and Time: The public conference will be held on May 23, 2011,
from 7 a.m. to 6:30 p.m. and May 24, 2011, from 7 a.m. to 4:30 p.m.
Location: The public conference will be held at the Key Bridge
Marriott Hotel, 1401 Lee Highway, Arlington, VA 22209, 1-703-524-6400,
FAX: 1-703-524-8964.
Contact Person: Wanda Neal, Parenteral Drug Association (PDA), PDA
Global Headquarters, Bethesda Towers, 4350 East-West Highway, suite
200, Bethesda, MD 20814, 1-301-656-5900, extension 111, FAX: 1-301-986-
1093, e-mail: [email protected].
Accommodations: Attendees are responsible for their own
accommodations. To make reservations at the Key Bridge Marriott Hotel,
at the reduced conference rate, contact the Key Bridge Marriott Hotel
(see Location), citing meeting code ``PDA.'' Room Rates are: Single/
Double: $229, plus applicable state and local. Reservations can be made
on a space and rate availability basis.
Registration: You are encouraged to register at your earliest
convenience. The PDA registration fees cover the cost of facilities,
materials, and breaks. Seats are limited; therefore, submit your
registration as soon as possible. Conference space will be filled in
order of receipt of registration. Onsite registration will be available
on a space available basis on the day of the public conference
beginning at 7 a.m. on May 23, 2011. The cost of registration is as
follows:
PDA Members................................................ $1,895.00
PDA Non-Members............................................ $2,144.00
Government/Health Authority PDA Member..................... $700.00
Government/Health Authority PDA Non-Member................. $700.00
PDA Member Academic........................................ $700.00
PDA Non-Member Academic/Health Authority................... $780.00
PDA Member Students........................................ $280.00
PDA Non-Member Students.................................... $310.00
If you need special accommodations due to a disability, please
attach a written description of your needs with your registration form.
Specific questions can be e-mailed to [email protected].
Registration Instructions: To register, please submit your
registration form online http://www.pda.org/glassquality2011 or by mail
to: PDA Global Headquarters, 4350 East West Highway, suite 150,
Bethesda, MD 20814. (FDA has verified the Web site address, but is not
responsible for subsequent changes to the Web site after this document
publishes in the Federal Register.)
SUPPLEMENTARY INFORMATION: Due to recent glass packaging quality issues
and recalls related to defects or incompatibilities with finished
product over the shelf life, pharmaceutical manufacturers and glass
suppliers have recognized the need for improvements in glass packaging
and glass handling practices throughout the product life cycle.
Appropriate standards, glass supplier reliability, and best practices
on glass handling and distribution are all necessary elements in the
maintenance of container integrity and product sterility assurance
throughout the product life cycle of sterile injectable pharmaceutical
and biopharmaceutical products. The 2-day public conference will cover:
Current issues with glass packaging,
Best practices on glass handling,
Current expectations for incoming glass and pharmaceutical
product packaging,
How to establish an effective glass supplier relationship
for product improvement, and
Improvements in glass manufacturing, characterization,
handling or packaging.
The conference program will include an exhibition on May 23 and 24,
2011.
Dated: April 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-10764 Filed 5-3-11; 8:45 am]
BILLING CODE 4160-01-P