QbD Development Process Evaluating Critical Steps 2019

Topics

• Critical quality attributes (CQA) is a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality
• Quality target product profile (QTPP) forms the basis for design and the development of the product. Considerations for the Quality Target Product Profile (ICH guideline Q8 R2)
• Risk Assessment (RA)one can recognizing critical attributes that are going to affect final quality of product
• Process Analytical Technology (PAT) which is a Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance

Who should Attend

• Regulatory Managers, Associates
• Regulatory Affairs Directors
• Technical Services Mangers
• Regulatory Compliance Directors, Manager
• Materials Management
• Plant Manager
• Quality Control Director, Manager