81 FR 49 pg. 13376 - The Fifth Annual Food and Drug Administration-International Society for Pharmaceutical Engineering Quality Conference
Type: NOTICEVolume: 81Number: 49Page: 13376
Page: 13376Docket number: [Docket No. FDA-2016-N-0001]
FR document: [FR Doc. 2016-05627 Filed 3-11-16; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
The Fifth Annual Food and Drug Administration-International Society for Pharmaceutical Engineering Quality Conference
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice of meeting.
SUMMARY:
The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research, in co-sponsorship with the International Society for Pharmaceutical Engineering (ISPE), is announcing a meeting entitled "Fifth Annual FDA-ISPE Quality Conference." The purpose of the meeting is to discuss manufacturing, compliance, and management practices that create, implement, and sustain a culture of high quality and result in reliable pharmaceutical and biologic products that support patient health.
DATES:
The meeting will be held on June 6, 7, and 8, 2016, from 8:30 a.m. to 4 p.m.
ADDRESSES:
The meeting will be held at the Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Rd., Bethesda, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Susan Krys, ISPE, 7200 Wisconsin Ave., Suite 305, Bethesda, MD 20814, 301-364-9202, FAX: 240-204-6024, email: skrys@ispe.org, or Sau (Larry) Lee, 301-796-2905, email: Sau.Lee@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
ISPE is an association of engineers, scientists, manufacturing, quality, and industrial professionals involved in the development, manufacture, quality control, and regulation of pharmaceuticals and related products. This co-sponsored meeting facilitates discussion and problem solving around technical, quality, compliance, and other manufacturing issues.
Registration: There is a registration fee to attend this meeting. The registration fee is charged to help defray the costs of programming and facilities. Seats are limited, and registration will be on a first-come, first-served basis.
To register, please complete registration online at http://www.ispe.org/events. FDA has verified the Web address, but FDA is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register . The costs of registration for the different categories of attendees are as follows:
| Category | Cost |
|---|---|
| Industry Representatives: | |
| ISPE Members | $1,895 (early-bird); $2,095 (onsite). |
| Non-members | $2,275 (early-bird); $2,475 (onsite). |
| Academic | $1,425 (early-bird); $1,575 (onsite). |
| Government | $700 (early-bird); $700 (onsite). |
Accommodations: Attendees are responsible for their own hotel accommodations. Attendees making reservations at the Bethesda North Marriott Hotel & Conference Center in Bethesda, MD are eligible for a reduced rate of $209 USD, not including applicable taxes. To receive the reduced rate, contact the Bethesda North Marriott Hotel (1-301-822-9200 or 1-800-859-8003) and identify yourself as an attendee of the meeting. If you need special accommodations due to a disability, please contact Susan Krys at least 7 days in advance.
Transcripts: We expect that transcripts will be available approximately 30 days after the meeting. A transcript will be available in either hard copy or on CD-ROM, after submission of a Freedom of Information request. The Freedom of Information office address is available on the Agency's Web site at http://www.fda.gov. Send faxed requests to 301-827-9267.
Dated: March 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05627 Filed 3-11-16; 8:45 am]
BILLING CODE 4164-01-P