Continued Process Verification

Overview:

The customer and regulatory agencies expectations are very clear. The product should be of consistent quality. The process validation is a tool which ensures the product is of consistent quality. 

However, to reach the expectations of regulatory agencies and customers, we can not just depend on the traditional/initial/prospective validation. 

As per the FDA expectations, “An ongoing program to collect and analyze product and process data that relate to product quality must be established (§ 211.180(e)). 

This training program will primarily focus on the concept and regulatory agencies expectations with practical approach for implementation of the continued process verification as a part of process validation life cycle approach.

Why you should Attend:

The learning objectives are firstly understanding the regulatory agencies expectations with practical approach for implementation of the continued process verification as a part of process validation life cycle approach. 

How Pharmaceutical organization personnel can ensure compliance and be able to comply the requirements. 

The benefits are:

• The person’s understanding about Phase III validation of process validation (CPV) will be clear
• The person working in pharmaceutical will become compliant in process validation requirements
• The person will get practical insight about implementation of continued process verification

Areas Covered in the Session:

The major points covered include

• Importance of topic and Agenda
• Know your Trainer
• Guideline Requirements - EU,FDA, WHO
• Understanding the FDA expectations about the Continued process verification 
• Sampling Considerations
• Practical view to implement - Points to consider
• Difference between EU and FDA
• Learning from Warning Letters

Who Will Benefit:

• Quality Assurance
• Quality Control
• Quality Engineering
• Quality Auditor
• Pharmaceutical Regulations and Regulatory Audit Compliance