2014 - Stability Program in Drug Development: A Comprehensive Approach

Overview:
The objective of this web seminar is to provide a comprehensive overview of the approach used to establish an effective and compliant stability program for small molecule pharmaceuticals. Discussion will include a thorough review of cGMP regulations and ICH Stability guidelines, development stability testing protocol supporting global markets, and strategies to minimize redundant testing for resource saving.
Why should you Attend:
Stability program is very costly; therefore, company must design an effective program to support the expiration dating of their drug product. With rapid development and constantly changing requirements of stability testing in pharmaceutical development, it is important to understand the regulations surrounding this area in order to design an effective stability program to support global markets.
Areas Covered in the Session:
Overview of stability role in the drug development process
Review warning letters and recent citations
Examine factors that may affect expiration dating of drug products
Understand cGMP regulatory requirements for stability testing
Impact of ICH regulations to Stability Program
Develop Global Stability Protocol
Who Will Benefit:
Laboratory Analysts
Quality Assurance scientists
QA/QC analysts
QA/QC managers
Auditors
Inspectors
Pharmaceutical development and manufacturing personnel
Manufacturers of raw materials and excipients
Contract laboratory Organization personnel
Quick Contact:
GlobalCompliancePanel
USA Phone:800-447-9407
Fax: 302-288-6884
webinars-AT-globalcompliancepanel.com
http://www.globalcompliancepanel.com
Event Link - http://bit.ly/1iRYMU1