Webinar on Risk Management for Pharmaceutical Change Control program

MessageThis Webinar is over
Date Apr 22, 2014
Time 12:00 PM EDT
Cost $195.00
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.
Kim Huynh-Ba has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She currently is the Executive Director of Pharmalytik, where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree on harmonization and optimization of analytical best practices since 2003.

Quick Contact:
USA Phone:800-447-9407
Event Link - http://bit.ly/1dS4Zan


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