QbD is based on the principle that quality cannot be tested into a product but should be built in by design. It is evident that these concepts need to be incorporated at the product development stage itself. To address the increased interest of global regulatory authorities, pharmaceutical companies are embracing the use of QbD principles throughout drug and drug product development.

This webinar is targeted towards explaining a systematic approach to product development using QbD principles. It begins with predefined design objectives and emphasizes product and process understanding, clinical trial requirements, and process control, based on sound science and quality risk management strategies. The discussions will be adequately supported by live examples and case studies.

In this webinar you’ll:

• Learn how to build meaningful product quality specifications that are based on clinical performance
• Enhance your understanding and control of product and process design to increase process capability and reduce product variability and defects
• Use this learning to help with regulatory approval and post-approval change management

Who should attend:

• Formulation Development and R&D team
• Pharmaceutical Production & Operations team
• QA/QC team
• Supply chain