ICH Q11- API Manufacturing

OVERVIEW

This program will address approaches to developing and understanding the manufacturing process for a drug substance. The information obtained will enable completion of the drug substance information in Module 3 of a CTD application. The webinar will address aspects of development and manufacture of the drug substance including steps to reduce impurities. Both traditional and enhanced approaches are discussed.

WHY SHOULD YOU ATTEND

This presentation 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.

AREAS COVERED

• Manufacturing process development
• Process controls
• Selection of starting materials
• Control strategy
• Process validation evaluation
• Submission of information
• Life cycle management

LEARNING OBJECTIVES

By the end of this program, attendees will understand the requirements of the Q11 guidance and learn skills for practical implementation of those requirements.

WHO WILL BENEFIT

• Quality Assurance
• Quality Control (Chem and Micro)
• Process and Design Engineering
• Process Automation
• Manufacturing Operations
• Validation
• Utility Operations
• Regulatory Affairs

For more detail please click on this below link:

https://bit.ly/2IYbQFR

Email: [email protected]

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616         

Fax: +1-888-909-1882

Others Details

Know the aspects of development and manufacture of the drug substance, including steps to reduce impurities. Also get a clear idea about both traditional and enhanced approaches.