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Process Validation, Quality By Design, Design Of Experiments


Course Description:

This course reviews and interprets the specific regulatory requirements and discusses current industry trends and regulatory hot topics. One of the recent FDA initiatives is to incorporate quality by design during product development. Pharmaceuticals manufacturing firms are faced with special requirements on validation of their processes and rigorous scrutiny from Regulatory Agencies that are well aware of the extent to which the process defines the product in this field.    A rational approach is presented to include consideration for Process Validation in all aspects of development including describtion of the Quality Assurance role, what must be accomplished as early as the process development lab bench, compliance considerations for raw materials, how process tolerances and uncertainties affect critical parameter ranges, scale up issues.  Special emphasis is given to parameter selection and evaluation, such as determining criticality, how to set valid ranges and when to use worst case studies.  


Who Should Attend:

Personnel in Development R&D,  Manufacturing, Validation, QA and QC involved in process validation and process control.