Current Trends in Pharmaceutical Process Validation - A Risk Based Approach

Overview

Validation of pharmaceutical manufacturing processes is a very important element of GMP in order to provide high level of confidence on the quality of finished product and is a mandatory compliance requirement of FDA. Risk based approach for process validation allows the management to focus on critical aspects of the manufacturing process and build adequate controls to ensure quality of the finished product.  The webinar not only provides an overview of the regulatory expectations in this aspect, but also provides an insight into how to execute the validation using risk approach to ensure a robust manufacturing process throughout the life cycle of the product.   

Why you should Attend

To understand and interpret regulatory expectations and develop a scientific approach to execute validation of the manufacturing process based on risk.  

Areas Covered in the Session

• Importance of process validation in building quality into the product based on FDA guideline on process validation
• Three stage approach to process validation, i.e Process design, Process qualification and Continuous process verification 
• Use of risk management tools to identify critical aspects and build appropriate controls 
• Master validation plan
• Formats and contents of validation protocol and report

Who Will Benefit

• Executives and Managers from QA/QC/R&D/Production/Tech transfer/regulatory functions