The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: June 17, 2021 at 10am to June 18, 2021 at 5pm
Street: Compliance Online, 2479 E. Bayshore Road
City/Town: Palo Alto
Website or Map: https://www.complianceonline.…
Event Type: seminae
Organized By: ComplianceOnline
Latest Activity: May 28, 2021
Results of analytical methods are used as the basis for important decisions during development and manufacturing of pharmaceutical products. All regulatory agencies expect the regulated industry to have procedures in place to ensure suitable levels of reliability, accuracy and precision of such methods. The procedures should cover lifecycle phases from design, development, validation to on-going routine use.
Managing analytical methods and procedures according to the lifecycle approach has been recommended in recent FDA guidance documents and stimuli articles published by the USP. For example, the recent FDA guidance “Analytical Procedures and Methods Validation for Drugs and Biologics” contains a section on Lifecycle Management of Analytical Procedures.
This 2-day workshop will explain the background to the new Analytical Procedure Lifecycle guidelines and give attendees the knowledge needed to implement recommended approaches. Interactive exercises will be included in the workshop.