Development of Solid Generic Formulations

Summary

This 2-day online training course will focus on the challenges of generic solid dosage forms development. It will help manufacturing managers establish an effective generic drug development program.

Learning Objectives

• Learn how to establish an effective generic drug development program
• Identify possible challenges encountered when moving to a new manufacturing site
• Introduce Quality by Design from the very start
• Find out how to set up a good transfer master plan
• Explore risks and critical process parameters for a solid dosage form

Key Topics

• Effective generic drug development program
• Expected Timelines and Influencing Factors
• The First Step of Formulation – The importance of the API
• BSC Classification
• The Roles of Excipients and Equipment
• Manufacturing Development
• Scale-up and Technology Transfer
• Regulatory Requirements

Who should attend?

Manufacturing Formulation Managers, Manufacturing Project Managers, Pharmaceutical Technologists, Process Development Scientists, Process Engineers, CMO Managers, Technology Transfer Specialists, Manufacturing Management, Regulatory Affairs Managers, Quality Assurance Managers

Our online training experience includes

• Our client zone – a single source for all training materials as well as pre and post-training communication
• Live interactive format via the Zoom platform
• Direct interaction with the trainer
• Q&As, case studies, polls
• Revisit recorded sessions for 30 days
• Digital and LinkedIn certificates