Practical and Compliance Approach to Cleaning Validation

Overview:

The cleaning validation is the key in all the pharmaceutical companies. Cleaning validation is performed in order to confirm the effectiveness of a cleaning procedure. Many people feel that, they are complying to the cleaning validation requirements. However, at many aspects, the companies fail to comply the cleaning validation requirements and further leading to serious actions by the regulators. Because, the cleaning validation is part of the CCP (Contamination Control Concept). So, with this study, the organization can ensure and prove that the product manufactured in the facility is complying to the purity requirements and there is no possibility of cross contamination in the product.

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.

• Risk assessment is applied to decide on the extent of cleaning validation studies
• Risk assessment based on product exposure is required to determine the need for validation of facility cleaning procedures
• The rationale for selecting limits of carryover of product residues, cleaning agents and microbial contamination must be based on scientific data and risk analysis procedures
• There is difference between finding the worst-case product and finding the worst-case limit. The attendee will understand this clearly
• Further, on attending, you will understand about how to survive for inspection with respect to cleaning validation

Areas Covered in the Session:

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

• Know your Trainer
• Importance of topic - FDA Citations
• Different regulatory requirements
• QRM in cleaning validation
• Cleaning validation - Finding worst case limit
• SMART objectives of cleaning validation
• Practical implementation approach
• Key points to consider during cleaning validation
• Detail discussion on acceptance limit, calculation of MACO
• Example of product - Calculation of MACO by following  different criteria
• Sampling methods
• Microbiological acceptance limit - Different criteria
• Surviving audit with cleaning validation aspect
• Discussion on LOD, LOQ, Recovery study
• Brief on CEHT,DEHT and campaign production
• Handling of new product introduction and inspection readiness.
• Q&A
• Vote of Thanks and contact details

Who Will Benefit:

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