Practical and Compliance Approach to Process Validation

Overview:

The process validation is the key in all the pharmaceutical companies. The process validation ensures that, all the products manufactured at site are with the consistent quality where not only quality attributes are considered but process parameters are also considered and ensured within the specification.

The non-conformity to the process validation requirements can lead to many serious actions and implications by the regulators. Because non-conformity to the process validation requirements is directly compromising the product quality and ultimately patient safety.

Why you should Attend:

Many companies failed to comply the requirements. Some of the requirements and detailed below. You will understand clearly about these requirements with the practical and compliance approach for implementation.

• A quality risk management- throughout the lifecycle of a medicinal product
• Decisions on the scope and extent of validation should be based on a justified and documented risk assessment
• Establishing an approach to control of the manufacturing process that results in products with the desired quality attributes
• Understand the sources of variation 
• Detect the presence and degree of variation 
• Understand the impact of variation on the process and ultimately on product attributes 
• Control the variation in a manner commensurate with the risk it represents to the process and product 
• Process design requirements and compliance

Areas Covered in the Session:

This training session will help all the attendees to understand the brief about the process validation in Pharmaceuticals. The agenda for the training session is as below; 

• Importance of topic & Know your Trainer
• Understanding different guideline expectations - EU, FDA, ANVISA,TGA  and WHO etc
• Common regulatory expectations
• Traditional approach and Hybrid approach, CQA and CPP 
• What is normally missing in process validation
• Concurrent validation approach
• Continued process verification vs product Quality Review
• Designing process validation protocol/Report
• Detailed difference between EU and FDA guide
• Q&A AND Vote of Thanks

Who Will Benefit:

• Quality Assurance
• Quality Control
• Pharmaceutical Compliance
• Global QA
• Corporate QA and QC