ICH Q11 - API Manufacturing
Duration : 90 Minutes
Peggy J Berry,
Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, Read more
This webinar 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.
Course Objective:
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. By the end of this program, attendees will understand the requirements of the Q11 guidance and learn skills for practical implementation of those requirements.
Course Outline:
• Manufacturing process development
• Process controls
• Selection of starting materials
• Control strategy
• Process validation evaluation
• Submission of information
• Life cycle management
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Quality Assurance Managers
• Quality Control Managers/Supervisors
• Process and Design Engineering Personnel
• Process Automation Staff
• Manufacturing Operations Staff
• Validation Specialists
• Utility Operations Staff
• Regulatory Affairs Personnel
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
