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The Fifth Annual Food and Drug Administration-International Society for Pharmaceutical Engineering Quality Conference

---
identifier: "/us/fr/2016-05627"
source: "fr"
legal_status: "authoritative_unofficial"
title: "The Fifth Annual Food and Drug Administration-International Society for Pharmaceutical Engineering Quality Conference"
title_number: 0
title_name: "Federal Register"
section_number: "2016-05627"
section_name: "The Fifth Annual Food and Drug Administration-International Society for Pharmaceutical Engineering Quality Conference"
positive_law: false
currency: "2016-03-14"
last_updated: "2016-03-14"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2016-05627"
document_type: "notice"
publication_date: "2016-03-14"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "81 FR 13376"
fr_volume: 81
docket_ids:
  - "Docket No. FDA-2016-N-0001"
fr_action: "Notice of meeting."
---

#  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: *[email protected],* or Sau (Larry) Lee, 301-796-2905, email: *[email protected].*

**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.