The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: February 27, 2014 from 10am to 11am
Location: Online Event
Street: 2600 E. Bayshore Road
City/Town: Palo Alto
Website or Map: http://www.complianceonline.c…
Event Type: pharmaceutical
Organized By: ComplianceOnline
Latest Activity: Feb 10, 2014
This webinar will explain the cGMP and ICH validation requirements for analytical procedures and discuss key factors that would affect validation process of analytical procedures. It will review the differences between validation and re-validation plan.
Why Should You Attend:
New medicines are developed every day to meet medical needs and improve quality of life. Analytical procedures are used to establish acceptance criteria and monitor quality of drug products. Therefore, validation becomes a critical process especially with the changes throughout the drug development process. It is important to understand validation requirements set forth by ICH and GMPs.
This webinar will present the common deficiencies in relation to method validation, outline regulatory requirements and the change control process needed to stay in compliance.
Upon completion of this session, attendees will understand cGMP and ICH validation requirements for analytical procedures and learn key factors that would affect validation process of analytical procedures. It would help scientists to develop process to evaluation method validation, review changes, and determine when re-validation would need to take place. It will discuss observations and infractions related to method validation.
Areas Covered in the Webinar:
Who will Benefit: