Regulatory and QA/QC Focus Elemental Impurity Analysis

October 28, 2013
Patricia Van Arnum
Pharmaceutical Technology

As the pharmaceutical industry prepares for changes to compendial and regulatory standards for elemental impurity analysis, QA/QC and laboratory scientists are tasked with adapting their operations to include data management, analysis, and reporting based on inductively coupled plasma–mass spectrometry (ICP–MS).

As the pharmaceutical industry prepares for changes to compendial and regulatory standards for elemental impurity analysis, QA/QC and laboratory scientists are tasked with adapting their operations to include data management, analysis, and reporting based on inductively coupled plasma–mass spectrometry (ICP–MS). Understanding the necessary technical controls to implement and manage analytical operations is crucial to ensure regulatory compliance. Pharmaceutical Technology will present a live educational webcast, “Achieving Regulatory Compliance When Moving to ICP-MS for Elemental Impurity Analysis,” on Wednesday, November 6, 11:00 AM to 12:00 PM EST to provide insight from leading industry experts on ICH, USP, and EMA guidelines for elemental impurity analysis and best practices and strategies to optimize the analytical workflow, data management, and data reporting when using ICP-MS.

The panelists for the webcast will be Mark Alasandro, PhD, Director of Pharmaceutical Analysis and Microbiology, Allergan, past chair of the PhRMA Stability Working Group, and member of the AAPS Steering Stability Focus Group Committee and Planning Committee; and Linda Doherty, PhD, Senior Product Manager, Software and Informatics Division, Agilent Technologies. Viewers will be able to ask questions of the panelists to gain further insight into compendial and regulatory requirements for elemental impurity analysis and on how to optimize analytical workflow, data management, and data reporting when using ICP-MS in elemental impurity analysis.

For additional information and to register for the Pharmaceutical Technology educational webcast, “Achieving Regulatory Compliance When Moving to ICP-MS for Elemental Impurity Analysis,” on Wednesday, November 6, 11:00 AM to 12:00 PM EST, click here.