FDA Florida District and ISPE Collaborate on Training

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USFDA Florida District and ISPE Collaborate to
Provide Free Training to the Industry

The U.S Food and Drug Administration, Florida District, in collaboration with the International Society for Pharmaceutical Engineering (ISPE), have collaborated to deliver training to address common violations found during inspections. This free training, specially designed to meet the needs of the local pharmaceutical industry, is scheduled for Thursday, 4 September 2014 and includes the following topics and speakers.

Welcome Remarks
Susan Turcovski, Director
Kathleen Sinninger, Director, Investigation Branch, Florida District

Good Manufacturing Practices – Most Common Deficiencies
CDR Ileana Barreto-Pettit, Investigator / Drug Specialist, Florida District

Oral Solid Dosage Forms
Rebeca Rodriguez, National, Expert Investigator Drugs Medical Products and Tobacco Program Operations Branch

Equipment Qualification
Tim Howard, PE, CPIP, Vice President of Global Operations, Commissioning Agents, Inc.

Process Validation
Steven Hertz, M.S., M.B.A., P.E. Consumer Safety Officer, Office of Manufacturing & Product Quality Office of Compliance, Center for Drugs Evaluation and Research

Cleaning Validation for the 21st Century
Andy Walsh, Stevens Institute of Technology

This event represents an excellent opportunity to meet and greet FDA officials, learn more about the Agency’s policy and procedures.

The training will take place at the Marriott Miami Airport located at 1201 NW 42 Ave, Miami, FL 33126.

Marriott Miami Airport has reserved a room block at a special rate of $99 per person; this special will be available until Friday, 22 August. To make a reservation or to schedule shuttle services from the airport, please call the hotel at (305) 649-5000.

Registration will begin at 7:30 AM prompt, followed by informational sessions from 8:00AM to 5:00PM.  To register please send an email to Ms. Cariny A. Nuñez, cariny.nunez@fda.hhs.gov, by 31 August.

Don’t miss out this great opportunity of interacting with FDA officials and ISPE members.

The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.

Please take our CDER Small Business survey: https://www.surveymonkey.com/s/CDERSBIA_Evaluation

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