Cleaning Validation – Practical Implementation & Compliance Approach

As, we all aware that, cross contamination is considered as critical because, it is directly linked to the patient safety. This training course will provide insight to attendees for practical implementation of cleaning validation and evaluate existing cleaning validation philosophy in line with regulatory requirements.

This training course provides practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. The course will describe the requirements for establishing an effective cleaning validation program, including the development of a general policy, cleaning SOPs and other appropriate documentation. In addition, participants will understand the requirements for maintaining a validated cleaning process.

Upon completion of the course, participants will learn and equipped to:

• How the theoretical worst case limit or product identified can be evaluated practically, how to handle practical problems faced during developing cleaning validation.
• Outline the importance and underlying principles of cleaning validation and the requirements to have adequate cleaning procedures for manufacturing equipment in contact with the product.
• Understand the FDA & other regulatory agencies perspectives , evaluate current loose threads on cleaning validation and areas of concern during regulatory inspections and become prepared to justify your own cleaning validation approach/ program so as to avoid high cost investment, time delays and /or adverse actions by regulatory agencies.
• Easy & pragmatic ways for developing protocol & report complying to different GMP regulations.