Comparability Protocols for Approved Drugs
About This Event
Description
This webinar will address approaches to developing comparability protocols for approved drugs, including primary content considerations and timing of submission. The information obtained will enable completion of appropriate testing to make changes to the drug substance or drug product formulation, manufacturing facility, and container closure. The webinar will address aspects of preparing the protocol prior to confirmed changes in order to speed approval and preparing the appropriate updates to Module 3 of the CTD.
Objectives of the Presentation
Value and effectiveness of a comparability protocol
How and when to prepare a comparability protocol
Receiving comments from the regulatory agency
Implementing and updating the comparability protocol
Why Should you Attend
Attend this training to determine whether or not a comparability protocol will provide you with future advantage in product life-cycle management.
Areas Covered
What is a comparability protocol
Format and content required for a comparability protocol
Considerations when making forward-thinking decisions for the protocol
Interactions with the Regulatory Agency
Advantages of a comparability protocol prior to approval & post-approval
Comparability protocol life-cycle management
Who can Benefit
This presentation is targeted toward the organizational positions and disciplines and is presented in practical language understandable by all technically educated or trained individuals, regardless of specialty. This information would be useful at levels from senior management to operative, and would be valuable for experience levels ranging from seasoned veterans to those newly assigned to roles related to manufacturing: Quality Assurance, Quality Control (Chem and Micro), Process and Design Engineering, Process Automation, Manufacturing Operations, Validation, Utility Operations, Regulatory Affairs.
For Registration
http://onlinecompliancepanel.com/webinar/COMPARABILITY-PROTOCOLS-APPROVED-DRUGS-501539/JUNE-2016-ES-WORLDCONCAL
Note: Use Promo code CHBSP and get 10% off on registration (Valid till June 30th 2016)