2011-10764. 2011 Parenteral Drug Association/Food and Drug Administration Glass Quality Conference; Public Conference

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public conference.

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: [phone].

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: [phone], e-mail: [e-mail].

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 [e-mail].

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.