Events

GPhA/FDA Fall Technical Conference 2009

Marriott Bethesda North Hotel and Conference Center

North Bethesda, MD

October 27 - 29, 2009

Fall Technical Conference | Sponsorship | Brochure and Agenda

BACK by Popular Demand! Pre-Conference Project Manager Workshop - October 27

Each year, during this half-day, pre-conference workshop, 30 U.S. Food and Drug Administration, Office of Generic Drugs project managers and industry attendees have the unique opportunity to ask questions and exchange information about ANDAs and other agency requirements.

Workshop Agenda

NEW for 2009! GPhA/USP: Analysis of Elemental Impurities Pre-Conference Workshop - October 27

This year, GPhA and USP offer this unique, full-day workshop for the following industry professionals who need to understand how to analyze metals and other elemental impurities in API's, excipients, and drug products:

• QC Manager
• Analytical Chemist
• QA Manager
• Compliance Manager
• Lab Manager
• Production Manager

Attendees learn about instrumental techniques, method development and validation strategies while developing an understanding of the strengths and weaknesses of ICP-OES and ICP-MS.

Upon completion of this workshop attendees understand the scope and context of USP's proposed new chapters on elemental impurities. The course is taught in light of the elements and limits proposed in the draft chapter <232> Elemental Impurities consistent with USP general chapter Plasma Spectrochemistry <730> and the default methodology proposed in draft chapter <233> Elemental Impurities - Procedures.

Workshop Agenda