2015-11620. 2015 International Society for Pharmaceutical Engineering/Food and Drug Administration/Product Quality Research Institute Quality Manufacturing 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 cosponsorship with the International Society for Pharmaceutical Engineering (ISPE), is announcing a meeting entitled “2015 ISPE/FDA/PQRI Quality Manufacturing Conference,” formerly known as the annually occurring “ISPE/FDA Current Good Manufacturing Practices Conference.” The purpose of the meeting is to discuss the quality of global pharmaceutical manufacturing and the combined efforts of industry leaders and regulators to modernize manufacturing facilities and processes to ensure quality and compliance.

DATES:

The meeting will be held on June 1 to 3, 2015, beginning at 7:30 a.m. on June 1 and ending at 4 p.m. on June 3.

ADDRESSES:

The meeting will be held at The Mayflower Renaissance, 1127 Connecticut Ave. NW., Washington, DC 20036. The hotel's phone number is 202-347-3000.

FOR FURTHER INFORMATION CONTACT:

John Bournas, President, International Society for Pharmaceutical Engineering, 600 North Westshore Blvd., Suite 900, Tampa, FL 33609, telephone: [phone], FAX: [phone], email: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

The International Society for Pharmaceutical Engineering is a not-for-profit international association of more than 20,000 engineers, scientists, manufacturing, quality and company executives, their suppliers, and regulatory agencies involved in the development, manufacture, quality control, and regulation of pharmaceuticals and related products. The goal of the conference is to ensure widespread opportunities for attendees to learn about important and critical issues that intersect with pharmaceutical manufacturing quality and regulatory topics that impact manufacturers, suppliers, and regulatory health authorities.

II. Registration

There is a registration fee to attend this meeting. The registration fee is charged to help defray the costs of conference sessions and presentations, facilities, materials, and food. 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/​2015-quality-manufacturing-conference/​fees-and-registration. (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
ISPE Members	$2,095
Nonmembers	2,475
Government	700

III. Accommodations

Attendees are responsible for their own hotel accommodations. Attendees making reservations at The Mayflower Renaissance, Washington DC, may check for the availability of a reduced rate by mentioning ISPE when making their reservation.

Dated: May 8, 2015.

Leslie Kux,

Associate Commissioner for Policy.