2014 - Risk Management for Pharmaceutical Change Control program

Overview:
Change is inevitable in the pharmaceutical industry. Manufacturing process changes and product changes are common post approval activities. Therefore, managing change is as much a business need as it is a regulatory need for pharmaceutical companies to stay in compliance. It is a process that can significantly impact the efficiency of an organization. This presentation will introduce a risk based approach and procedure with regard to severity, likelihood and detection to manage the change control program.
Why should you attend:
Specifications of pharmaceuticals products are defined based on the identity, strength, quality, purity. Therefore, when changes occur, quality and efficacy of the products would be at risk. Companies must have a good change control program to keep the product in compliance with current regulations.
Areas Covered in the Session:
Identify potential problems
Assess the current state process
Determine likely causes
Define the desired future state process
System validation
Plan training and implementation
Monitor continuous improvement and support
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
webinars-AT-globalcompliancepanel.com
http://www.globalcompliancepanel.com
Event Link - http://bit.ly/1nIrl8c