Date: | April 22, 2014 - 10:00am - 11:00am |
Timezone: | (GMT-08:00) Pacific Time (US & Canada) |
Location: | 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA, Fremont, CA, 94539, United States |
Website for Event: | http://bit.ly/1dS4Zan |
Topic: | Health Products and Services |
Description: | 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 Who Will Benefit: Laboratory Analysts 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. Her clients are from various sizes of pharmaceutical companies in US and abroad. Quick Contact: GlobalCompliancePanel |
Contact Name: | John Robinson |
Contact Email: | globalcompliancepanel@gmail.com |
Contact Phone: | 8004479407 |