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@globalcompliancepanel.com
http://www.globalcompliancepanel.com
For More Info Click Here